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jobs
Medical/Clinical Research
Chiddi Domike ARpharmS
,
Ickenham, United Kingdom
Experience
Skills
I'm offering
Clinical research
Markets
United States
United Kingdom
Available
My experience
2020 - ?
job
Senior Regulatory Specialist
unknown.
Duties and Responsibilities:
Liaise with SAR colleagues to drive plan, organize, compile, progress, track and submit regulatory submissions on a timely basis and with a consistently high level of quality
May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
Where required provide local QC of submission dossiers prior to dispatch
Effectively and proactively communicate to the SAR Lead and relevant project team members the status and action plans concerning submissions
Proactively identify risks; generate effective mitigation strategies, action plans, and follow to full resolution
Foster professional working relationships with internal and external contacts to ensure expeditious submission/approval of regulatory dossiers
Maintain country specific patient information sheet and consent form customization text
Maintain country specific drug labelling information
Maintain Country Intelligence Pages
Be familiar with and comply with SOPs, ICH GCP and applicable regulations
Stay informed of changing regulatory legislative requirements and maintain regulatory intelligence database
Advise the SAR project team about appropriate regulatory strategies
Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements
Provide timely and relevant updates and communication of changes in the regulatory environment to the Regulatory Affairs department
Be or become an established and recognized subject matter expert on regulatory affairs
Provide advice to the Regulatory Affairs department on interpretation of new legislation, guidance and directives
Proactively identify potential improvements to processes, quality and overall delivery
Train SAR colleagues to foster quality delivery throughout the SAR department
May support feasibility, site identification or essential document packet activities as needed for critical delivery or for professional self-development if desired
Liaise with SAR colleagues to drive plan, organize, compile, progress, track and submit regulatory submissions on a timely basis and with a consistently high level of quality
May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
Where required provide local QC of submission dossiers prior to dispatch
Effectively and proactively communicate to the SAR Lead and relevant project team members the status and action plans concerning submissions
Proactively identify risks; generate effective mitigation strategies, action plans, and follow to full resolution
Foster professional working relationships with internal and external contacts to ensure expeditious submission/approval of regulatory dossiers
Maintain country specific patient information sheet and consent form customization text
Maintain country specific drug labelling information
Maintain Country Intelligence Pages
Be familiar with and comply with SOPs, ICH GCP and applicable regulations
Stay informed of changing regulatory legislative requirements and maintain regulatory intelligence database
Advise the SAR project team about appropriate regulatory strategies
Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements
Provide timely and relevant updates and communication of changes in the regulatory environment to the Regulatory Affairs department
Be or become an established and recognized subject matter expert on regulatory affairs
Provide advice to the Regulatory Affairs department on interpretation of new legislation, guidance and directives
Proactively identify potential improvements to processes, quality and overall delivery
Train SAR colleagues to foster quality delivery throughout the SAR department
May support feasibility, site identification or essential document packet activities as needed for critical delivery or for professional self-development if desired
Database, Support, Regulatory Affairs, Regulatory, Development, QC, Processes
2020 - 2020
job
International Regulatory Affairs Liaison
Gilead Sciences Inc.
Duties and Responsibilities:
• Responsibility for the preparation of regulatory submissions for investigational and commercial products in assigned therapeutic area.
• For development medicinal products prepares and/or co-ordinates the preparation of regulatory documentation to support Clinical Trial Applications/ amendments, and attends Clinical Study Management (SMT) meetings, as required.
• For licensed products, prepare and/or co-ordinate the submission of non-clinical, clinical and safety regulatory documentation in accordance with regulations, post licensing commitments and legal obligations of the marketing Authorization Holder via the European Centralized procedure, e.g. variations, PSURs, RMPs, responses to questions and renewals etc.
• Support scientific advice procedures and Pediatric Investigation Plans (PIP) in the European Union.
• Interacts with the US regulatory, Clinical Research and Clinical Operations team leads to ensure optimal execution of the agreed regulatory strategy for development medicinal
products.
• Represents International Regulatory function at cross functional submission/study
management team meetings.
• For licensed products, may be responsible for ensuring product packaging and associated
information is updated and maintained in accordance with product licenses, in international territories, including the review of artwork and the provision of accurate labelling translations.
• Provide advice and practical input on labeling issues across the development and marketed product portfolio
• Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams and senior management.
• Participate in regulatory team meetings and present project status updates.
• Responsibility for the preparation of regulatory submissions for investigational and commercial products in assigned therapeutic area.
• For development medicinal products prepares and/or co-ordinates the preparation of regulatory documentation to support Clinical Trial Applications/ amendments, and attends Clinical Study Management (SMT) meetings, as required.
• For licensed products, prepare and/or co-ordinate the submission of non-clinical, clinical and safety regulatory documentation in accordance with regulations, post licensing commitments and legal obligations of the marketing Authorization Holder via the European Centralized procedure, e.g. variations, PSURs, RMPs, responses to questions and renewals etc.
• Support scientific advice procedures and Pediatric Investigation Plans (PIP) in the European Union.
• Interacts with the US regulatory, Clinical Research and Clinical Operations team leads to ensure optimal execution of the agreed regulatory strategy for development medicinal
products.
• Represents International Regulatory function at cross functional submission/study
management team meetings.
• For licensed products, may be responsible for ensuring product packaging and associated
information is updated and maintained in accordance with product licenses, in international territories, including the review of artwork and the provision of accurate labelling translations.
• Provide advice and practical input on labeling issues across the development and marketed product portfolio
• Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams and senior management.
• Participate in regulatory team meetings and present project status updates.
Marketing, Operations, Research, Packaging, Artwork, Management, Safety, Support, Regulatory Affairs, Regulatory, Development, International, Medicinal
2017 - 2020
job
Regulatory Advisor
IQVIA.
Duties and responsibilities:
• Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/including acting as a Project Manager for a stand-alone project.
• Competently reviews/writes regulatory and/or technical documents (including ICF, ATMP -GMO Applications and Submissions, CT-Labels, SmPC's, PIL's, EC and Competent Authorities Submissions) where required.
• Clinical Study submissions support and provision of information as required for Product Registration in designated markets including site and establishment registrations including FDA 510(k), CE Marking etc.
• Resolution of CAPAs, complaint handling process /Post market surveillance, and other appropriate regulatory responsibilities.
• Providing expertise and guidance on regulatory processes for drug development including but not limited to CTA/MAA/ Variations applications, First in Human Studies, ODD (Orphan Drug Development) PIP (Paediatric Investigational Plans) and Compassionate use programme.
• Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned.
• Adopts a proactive and flexible approach to resolve any issues.
• Undertakes detailed review and management of budgets related to projects, including out of scope activities.
• Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate.
• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
• Present to clients at bid defence meetings by phone or in person, for a range of regulatory deliverables.
• May be involved in a Regulatory and/or Quintiles Initiative.
• Performs other tasks or assignments, as delegated by Regulatory management.
• Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/including acting as a Project Manager for a stand-alone project.
• Competently reviews/writes regulatory and/or technical documents (including ICF, ATMP -GMO Applications and Submissions, CT-Labels, SmPC's, PIL's, EC and Competent Authorities Submissions) where required.
• Clinical Study submissions support and provision of information as required for Product Registration in designated markets including site and establishment registrations including FDA 510(k), CE Marking etc.
• Resolution of CAPAs, complaint handling process /Post market surveillance, and other appropriate regulatory responsibilities.
• Providing expertise and guidance on regulatory processes for drug development including but not limited to CTA/MAA/ Variations applications, First in Human Studies, ODD (Orphan Drug Development) PIP (Paediatric Investigational Plans) and Compassionate use programme.
• Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned.
• Adopts a proactive and flexible approach to resolve any issues.
• Undertakes detailed review and management of budgets related to projects, including out of scope activities.
• Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate.
• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
• Present to clients at bid defence meetings by phone or in person, for a range of regulatory deliverables.
• May be involved in a Regulatory and/or Quintiles Initiative.
• Performs other tasks or assignments, as delegated by Regulatory management.
Project Manager, Writing, Training, REST, Management, Technical Writing, Support, Regulatory, Development, CE marking, Processes, Manager
2018 - 2019
job
Study Start Up Delivery Lead
Allergan Ltd.
Duties and responsibilities:
The Start-up Delivery Lead (SDL) is the key point of contact between Allergan (AGN) study teams and the affiliate partner (vendor) for Phase II-III trials in EMEA. The main responsibilities of the Start Up Delivery Lead are to:
• manage and oversee the activities of the affiliate partner, including start up activities
(project set up, regulatory/EC submissions, site contracts, essential document collection, IMP release and site activation) and maintenance activities (ongoing regulatory and ethics submissions, management of protocol and contract amendments).
• oversee the activities of AGN Contracts Managers (CM) and Site Start-Up Associates (SSA) assigned to their respective studies
Vendor Engagement:
• engaging and training GCTM on the EMEA Affiliate model.
• working with GCTM to tailor the operational plan and templates for each
study (e.g. ISAM Plan);
• working with the vendor to setup kick-off and ongoing meetings as well as assuring these meetings are effective.
• managing the vendor for day to day operations.
• acting as a single point of contact for all escalations in relation to start-up
for both AGN and the vendor.
• ongoing financial management of affiliate budget (e.g. forecasts, accruals).
• Identifying key risks (e.g. availability of core documents, site lists, timeline risks etc.) in partnership with vendor and study team
Metrics and Reporting:
• Tracking and reporting start-up metrics, timelines and justifications for any delays to the AGN study team and senior management as required.
Trial Master File:
• ensuring that the TMF plan is appropriately followed for each study.
Regulatory/ Ethics Submission:
Working with the AGN study team and vendor to generate a clear
submission strategy and proactively reassessing the strategy
• Ensuring that submission documents are provided in a timely manner.
• Overseeing SSA review of changes such as safety or legal language for region, country, and site specific ICFs.
• Reviewing a sampling of submissions packs for quality and completeness
• Coordinating and taking a lead role in responding to Reg/EC queries & determination of substantial/non-substantial amendments.
• Tracking CTA activities including timelines and milestones and communicating the CTA submissions and approvals to relevant parties.
• Ensuring all post-approval submissions are performed for the complete
lifecycle of the assigned studies (e.g. amendments, end of trial notifications, DSURs & Clinical Study Reports);
• Keeping abreast of developments in legislation and guidelines applicable
to clinical trials and train team members as appropriate.
• Monitoring for and escalating potential delays to regulatory and ethics
Submissions
Site Selection, Activation and Essential Documents:
During site selection, the SDL will oversee the SSAs in:
• Liaising with GCTM and FACT to ensure potential sites are tracked and communicated to the vendor start up team appropriately.
• Notifying sites of non-selection.
• Monitoring for and escalating potential delays to site selection timelines
During site activation and maintenance, SDL will oversee the SSAs in:
• Working with GCTM to ensure a clear strategy for the delivery of training, equipment supplies and any other pre-activation requirements.
• Reviewing/approving IP release and site activation checklist templates to be used in each country.
• Supporting escalations from the vendor in relation to essential document collection, ISF generation, IP release or site activation.
• Monitoring for and escalating potential delays to site activation timelines
Site Contracts
The SDL will oversee the CMs* in:
• Ensuring that the vendor generates suitable site contract templates and budgets.
• Managing routine site contract related escalations & triaging them to the appropriate Allergan teams (e.g. site contract experts, legal, GCTM, etc.)
• Reviewing a sampling of site contracts for quality.
• Monitoring for and escalating potential delays to site contract timelines.
Other Duties
• Support, line manage, and train less experienced team members as required.
Lead business projects or other teams as assigned by management.
The Start-up Delivery Lead (SDL) is the key point of contact between Allergan (AGN) study teams and the affiliate partner (vendor) for Phase II-III trials in EMEA. The main responsibilities of the Start Up Delivery Lead are to:
• manage and oversee the activities of the affiliate partner, including start up activities
(project set up, regulatory/EC submissions, site contracts, essential document collection, IMP release and site activation) and maintenance activities (ongoing regulatory and ethics submissions, management of protocol and contract amendments).
• oversee the activities of AGN Contracts Managers (CM) and Site Start-Up Associates (SSA) assigned to their respective studies
Vendor Engagement:
• engaging and training GCTM on the EMEA Affiliate model.
• working with GCTM to tailor the operational plan and templates for each
study (e.g. ISAM Plan);
• working with the vendor to setup kick-off and ongoing meetings as well as assuring these meetings are effective.
• managing the vendor for day to day operations.
• acting as a single point of contact for all escalations in relation to start-up
for both AGN and the vendor.
• ongoing financial management of affiliate budget (e.g. forecasts, accruals).
• Identifying key risks (e.g. availability of core documents, site lists, timeline risks etc.) in partnership with vendor and study team
Metrics and Reporting:
• Tracking and reporting start-up metrics, timelines and justifications for any delays to the AGN study team and senior management as required.
Trial Master File:
• ensuring that the TMF plan is appropriately followed for each study.
Regulatory/ Ethics Submission:
Working with the AGN study team and vendor to generate a clear
submission strategy and proactively reassessing the strategy
• Ensuring that submission documents are provided in a timely manner.
• Overseeing SSA review of changes such as safety or legal language for region, country, and site specific ICFs.
• Reviewing a sampling of submissions packs for quality and completeness
• Coordinating and taking a lead role in responding to Reg/EC queries & determination of substantial/non-substantial amendments.
• Tracking CTA activities including timelines and milestones and communicating the CTA submissions and approvals to relevant parties.
• Ensuring all post-approval submissions are performed for the complete
lifecycle of the assigned studies (e.g. amendments, end of trial notifications, DSURs & Clinical Study Reports);
• Keeping abreast of developments in legislation and guidelines applicable
to clinical trials and train team members as appropriate.
• Monitoring for and escalating potential delays to regulatory and ethics
Submissions
Site Selection, Activation and Essential Documents:
During site selection, the SDL will oversee the SSAs in:
• Liaising with GCTM and FACT to ensure potential sites are tracked and communicated to the vendor start up team appropriately.
• Notifying sites of non-selection.
• Monitoring for and escalating potential delays to site selection timelines
During site activation and maintenance, SDL will oversee the SSAs in:
• Working with GCTM to ensure a clear strategy for the delivery of training, equipment supplies and any other pre-activation requirements.
• Reviewing/approving IP release and site activation checklist templates to be used in each country.
• Supporting escalations from the vendor in relation to essential document collection, ISF generation, IP release or site activation.
• Monitoring for and escalating potential delays to site activation timelines
Site Contracts
The SDL will oversee the CMs* in:
• Ensuring that the vendor generates suitable site contract templates and budgets.
• Managing routine site contract related escalations & triaging them to the appropriate Allergan teams (e.g. site contract experts, legal, GCTM, etc.)
• Reviewing a sampling of site contracts for quality.
• Monitoring for and escalating potential delays to site contract timelines.
Other Duties
• Support, line manage, and train less experienced team members as required.
Lead business projects or other teams as assigned by management.
Operations, Budget, Contracts, CMS, Training, Management, Less, Safety, Support, SSAS, Affiliate, Monitoring, Regulatory, Contracts, UP
2016 - 2017
job
Clinical and Regulatory Start up Manager
Premier Research Group.
Duties and responsibilities:
POSITION SUMMARY:
Performs the role of Clinical and Regulatory Start-Up Lead (CRSUL). Key tasks include liaising and/or interfacing with the Sponsor to provide all documents in a timely manner, finalizing core study documents with the Sponsor ready for in-country use, developing the start-up and regulatory strategy and plan through to sign-off, driving CA/CEC/LEC submissions, overseeing site contract execution performance, overseeing regulatory approval of IP release, as well as any other start-up component as established, including collaboration to general study timelines. Performs submissions as required and may act as Start-up Manager at the country where he/she is based.
Ensures continuous improvement of quality in all Regulatory and Start-up components at the project level (clinical trial applications, essential document collection, communication to Competent Authority and Ethics Committees, etc.).
ACCOUNTABILITY:
The Clinical and Regulatory Start-up Lead:
• Prepares Core Clinical Trial Applications for competent authorities including ATMP-GMO applications
• Drives the overview of applications done by Start-up Managers to competent authority (CA) and Ethics Committees /IRBs, as well as planning and tracking other Start-up components like Import Licenses, Essential Documents, Site Contracts, etc.
RESPONSIBILITIES:
1. For Start-up and Regulatory success:
• Assumes responsibility on deliverables in Regulatory and Start-up at the project level following the project requirements and the applicable rules.
• Complies with forecasted submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, escalates the problem as soon as identified.
• Produces or review some submission components like the Patient Information Form/ICF and or Investigational Medicinal Product Dossier (IMPD) or equivalent document as required.
• May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.
2. For commercial success:
• At all times to maintain good, friendly and professional relationships with past, current and potential sponsors, and others with whom the company works
• Contributes to the business development process by reviewing proposals, budgets and attending client meetings.
• Reviews proposals attends client sales-focused meetings and provides information to support business development activities.
• Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately.
3. Other
• Participate in corporate initiatives and actions that ensure the continued success of the company
• Keeps abreast of scientific developments and maintain technical expertise by attending courses, meetings, reading the literature and following announcements on the relevant websites
• Works with the PM to understand financial aspects of the project; cascades to all start-up team members the number of hours/tasks available per contract; monitors project performance.
• Uses professionally recognized tools for planning and management of scope, timeline, resources, and budget. Ensures that minimum hours are used for tasks and that the Project Manager (PM) is pursuing out-of-scope work via the Change Order or financial reconciliation processes.
POSITION SUMMARY:
Performs the role of Clinical and Regulatory Start-Up Lead (CRSUL). Key tasks include liaising and/or interfacing with the Sponsor to provide all documents in a timely manner, finalizing core study documents with the Sponsor ready for in-country use, developing the start-up and regulatory strategy and plan through to sign-off, driving CA/CEC/LEC submissions, overseeing site contract execution performance, overseeing regulatory approval of IP release, as well as any other start-up component as established, including collaboration to general study timelines. Performs submissions as required and may act as Start-up Manager at the country where he/she is based.
Ensures continuous improvement of quality in all Regulatory and Start-up components at the project level (clinical trial applications, essential document collection, communication to Competent Authority and Ethics Committees, etc.).
ACCOUNTABILITY:
The Clinical and Regulatory Start-up Lead:
• Prepares Core Clinical Trial Applications for competent authorities including ATMP-GMO applications
• Drives the overview of applications done by Start-up Managers to competent authority (CA) and Ethics Committees /IRBs, as well as planning and tracking other Start-up components like Import Licenses, Essential Documents, Site Contracts, etc.
RESPONSIBILITIES:
1. For Start-up and Regulatory success:
• Assumes responsibility on deliverables in Regulatory and Start-up at the project level following the project requirements and the applicable rules.
• Complies with forecasted submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, escalates the problem as soon as identified.
• Produces or review some submission components like the Patient Information Form/ICF and or Investigational Medicinal Product Dossier (IMPD) or equivalent document as required.
• May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.
2. For commercial success:
• At all times to maintain good, friendly and professional relationships with past, current and potential sponsors, and others with whom the company works
• Contributes to the business development process by reviewing proposals, budgets and attending client meetings.
• Reviews proposals attends client sales-focused meetings and provides information to support business development activities.
• Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately.
3. Other
• Participate in corporate initiatives and actions that ensure the continued success of the company
• Keeps abreast of scientific developments and maintain technical expertise by attending courses, meetings, reading the literature and following announcements on the relevant websites
• Works with the PM to understand financial aspects of the project; cascades to all start-up team members the number of hours/tasks available per contract; monitors project performance.
• Uses professionally recognized tools for planning and management of scope, timeline, resources, and budget. Ensures that minimum hours are used for tasks and that the Project Manager (PM) is pursuing out-of-scope work via the Change Order or financial reconciliation processes.
Sales, Manager, UP, Processes, Contracts, Medicinal, Development, Regulatory, Support, Business development, SoMe, Management, Continuous improvement, Websites, Contracts, Budget, Project Manager
2015 - 2016
job
Regulatory Specialist
Novella Clinical.
Duties and responsibilities:
BASIC FUNCTIONS:
To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. To provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and organizations; to support regulatory agency interactions, communications, and submissions; and to review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
• Works with Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance issued by the applicable regulatory agency(ies).
• Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
• Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
• Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.
• Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated Novella activities, as appropriate.
• Serve as Novella liaison with central IRBs.
• Perform other related duties as assigned.
• Providing comprehensive operational support to ensure clinical trial study deliverables are achieved globally (excluding USA)
- Supporting Area & Affiliate Regulatory Affairs colleagues responsible for development compounds with strategic and operational activities in the below geographic regions:
*Western Europe
*Eastern Europe, Middle East and Africa
*Latin America
*Japan and Asia Pac Countries
- Provide advice on submission strategy (e.g. VHP vs National)
- Serve on CTA submission team meetings as the regulatory representative
- Provide ad hoc support for CTA related projects
BASIC FUNCTIONS:
To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. To provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and organizations; to support regulatory agency interactions, communications, and submissions; and to review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
• Works with Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance issued by the applicable regulatory agency(ies).
• Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
• Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
• Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.
• Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated Novella activities, as appropriate.
• Serve as Novella liaison with central IRBs.
• Perform other related duties as assigned.
• Providing comprehensive operational support to ensure clinical trial study deliverables are achieved globally (excluding USA)
- Supporting Area & Affiliate Regulatory Affairs colleagues responsible for development compounds with strategic and operational activities in the below geographic regions:
*Western Europe
*Eastern Europe, Middle East and Africa
*Latin America
*Japan and Asia Pac Countries
- Provide advice on submission strategy (e.g. VHP vs National)
- Serve on CTA submission team meetings as the regulatory representative
- Provide ad hoc support for CTA related projects
Research, Strategic Planning, Training, Compliance, Quality Assurance, Support, Regulatory Affairs, Affiliate, Regulatory, Development, USA, Asia, Manager, Basic
2015 - 2015
freelance
Consultant
Leica Biosystems Newcastle Ltd.
Duties and responsibilities:
• Continuous review of products against the target/required market requirements
• Responsibility for the amendment/update of product labeling, IFUs and Safety data sheets.
• Global submissions/registrations of Products/ Licenses
• Management and oversight of change control procedures, project management and document control via SAP
• Planning, management and execution of CLP compliance project globally for all affected non-hazardous and hazardous products.
• Initiating, developing and implementing regulatory strategies for new technologies, product modification etc.
• Driving the process of meeting requirements established by FDA and International government agencies with respect to devices to market.
• Initiating change orders and assessing the regulatory impact of product changes on European and Rest of the World Markets.
• Supporting post-market regulatory compliance activities for International and foreign product manufacturers.
• Planning and preparing PMA and 510(K) FDA submissions.
• Continuous review of products against the target/required market requirements
• Responsibility for the amendment/update of product labeling, IFUs and Safety data sheets.
• Global submissions/registrations of Products/ Licenses
• Management and oversight of change control procedures, project management and document control via SAP
• Planning, management and execution of CLP compliance project globally for all affected non-hazardous and hazardous products.
• Initiating, developing and implementing regulatory strategies for new technologies, product modification etc.
• Driving the process of meeting requirements established by FDA and International government agencies with respect to devices to market.
• Initiating change orders and assessing the regulatory impact of product changes on European and Rest of the World Markets.
• Supporting post-market regulatory compliance activities for International and foreign product manufacturers.
• Planning and preparing PMA and 510(K) FDA submissions.
Project Management, SAP, REST, Management, Compliance, Safety, Regulatory, International
2014 - 2015
freelance
Regulatory Consultant
Abbott Healthcare Products.
Duties and responsibilities:
• Activities associated with the licensing of pharmaceutical products within the Client Company's portfolio in the UK, specifically, but not limited to, the following projects:
The review of SmPCs and PILs against the Core Company Documents (CCDS)
• To compile and submit the necessary variations packages to align the SmPCs and PILs to CCDS.
• To act upon the post-approval activities of these submissions.
• To compile, review and submit all required variation submission packages including but not limited to Type 1A, 1B, 11 and Art 61(3) notifications in line with company processes.
• Product and therapy area portfolio responsibilities including lifecycle maintenance for assigned products
• Activities associated with the licensing of pharmaceutical products within the Client Company's portfolio in the UK, specifically, but not limited to, the following projects:
The review of SmPCs and PILs against the Core Company Documents (CCDS)
• To compile and submit the necessary variations packages to align the SmPCs and PILs to CCDS.
• To act upon the post-approval activities of these submissions.
• To compile, review and submit all required variation submission packages including but not limited to Type 1A, 1B, 11 and Art 61(3) notifications in line with company processes.
• Product and therapy area portfolio responsibilities including lifecycle maintenance for assigned products
Pharmaceutical, Regulatory, Processes
2013 - 2014
job
Senior Regulatory Executive
Glaxo Smithkline, Stockley Park.
Duties and responsibilities:
• Review local and global labelling assessments to ensure compliance with company Global Datasheet.
• Maintain continuous interface as well provide directions to local operating companies with the view of ensuring quality and compliance for product labels
• Review and priortise submissions to support the revision of Patient information for products registered globally
• Ensure delivery to time and quality targets
• Project management for the maintenance of Product Information [Patient Information Leaflets (PILs) and Summary of Product Characteristics (SmPCs), labels]
• Management and oversight of regulatory responsibilities for the implementation of local requirements
• Advice on labelling related to local regulatory requirements
• Maintain awareness of and support compliance to European and especially local regulatory requirements
• Responsible for coordination of local competent authority interactions as required for the maintenance and compliance of approved products
• Budget responsibilities and resource planning
• Staff development, performance management and development plans
• Review local and global labelling assessments to ensure compliance with company Global Datasheet.
• Maintain continuous interface as well provide directions to local operating companies with the view of ensuring quality and compliance for product labels
• Review and priortise submissions to support the revision of Patient information for products registered globally
• Ensure delivery to time and quality targets
• Project management for the maintenance of Product Information [Patient Information Leaflets (PILs) and Summary of Product Characteristics (SmPCs), labels]
• Management and oversight of regulatory responsibilities for the implementation of local requirements
• Advice on labelling related to local regulatory requirements
• Maintain awareness of and support compliance to European and especially local regulatory requirements
• Responsible for coordination of local competent authority interactions as required for the maintenance and compliance of approved products
• Budget responsibilities and resource planning
• Staff development, performance management and development plans
Project Management, Budget, Performance Management, Management, Compliance, Implementation, Support, Regulatory, Revision, Development
2013 - 2013
job
Quintiles CRO
unknown.
Position: Global Regulatory and Start Up Lead
Duties and responsibilities:
Direct and manage the delivery of all required start-up, maintenance and regulatory activities or selected studies as determined by either the agreed algorithm or the Sponsor's requirements, including pre-award activities, oversight of the scope of work, budget and resources.
Core responsibilities
• Oversee the execution of Startup (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy.
• Develop, implement and maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy.
• Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Assist with creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
• Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required.
• Work with Quality Management to ensure appropriate quality standards for the duration of the project.
• Mentor and coach colleagues as required.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
• May take a proactive role in developing longstanding relationships with preferred Quintiles customers.
• Deliver presentations/training to clients, colleagues and professional bodies, as required.
Duties and responsibilities:
Direct and manage the delivery of all required start-up, maintenance and regulatory activities or selected studies as determined by either the agreed algorithm or the Sponsor's requirements, including pre-award activities, oversight of the scope of work, budget and resources.
Core responsibilities
• Oversee the execution of Startup (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy.
• Develop, implement and maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy.
• Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Assist with creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
• Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required.
• Work with Quality Management to ensure appropriate quality standards for the duration of the project.
• Mentor and coach colleagues as required.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
• May take a proactive role in developing longstanding relationships with preferred Quintiles customers.
• Deliver presentations/training to clients, colleagues and professional bodies, as required.
Business development, Budget, Training, Mentor, Management, Compliance, Quality Management, Support, Regulatory, Cro, Development, Coach, UP, CTMS
2012 - 2013
job
Regulatory Labelling Manager
Roche Products Ltd.
Duties and responsibilities:
• Define and deliver a carefully planned and well executed strategy to achieve accurate and high-quality labelling services globally
• Develop robust guidelines and processes to achieve consistency and quality in the area of labeling management
• Application of expertise in global regulatory requirements, best practice processes and standardized methodology in label management
• Ensuring that all new labels and or updates are planned managed and delivered at a consistently high standard.
• Ensuring the meticulous management of the Core Data Sheet in collaboration with internal regulatory product teams, safety and clinical sciences and other subject matter experts within and outside Roche.
• Responsibility for collaborative planning and strategic alignment of best practices across Roche sites.
• Advice internally on matters pertaining to policy, technical issues and regulations, and acting as SME on issues related to guidance across the organization.
• Working with affiliates and regulatory experts within Roche worldwide to meet and promote compliance standards in local product information.
• Define and deliver a carefully planned and well executed strategy to achieve accurate and high-quality labelling services globally
• Develop robust guidelines and processes to achieve consistency and quality in the area of labeling management
• Application of expertise in global regulatory requirements, best practice processes and standardized methodology in label management
• Ensuring that all new labels and or updates are planned managed and delivered at a consistently high standard.
• Ensuring the meticulous management of the Core Data Sheet in collaboration with internal regulatory product teams, safety and clinical sciences and other subject matter experts within and outside Roche.
• Responsibility for collaborative planning and strategic alignment of best practices across Roche sites.
• Advice internally on matters pertaining to policy, technical issues and regulations, and acting as SME on issues related to guidance across the organization.
• Working with affiliates and regulatory experts within Roche worldwide to meet and promote compliance standards in local product information.
Management, Compliance, Safety, Regulatory, Processes, Manager
2011 - 2012
job
Hub Labelling Manager
Pfizer Ltd.
Duties and responsibilities:
• Utilize regulatory expertise to review, develop and deliver core-labelling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice from others when appropriate.
• Engage in necessary labelling team meetings to discuss any decisions for not making any label updates or discuss any findings of meaningful differences for registration types specific to USPIs, CRP-SmPCs and MRP/DCP-SmPCs as necessary
• Employ a consistent approach to the content of labelling documents assuring that governing SOPs and IG's are followed and external regulations are met.
• Ensure that decisions taken for labeling are accurately captured and communicated to appropriate stakeholders so that local and regional submission activities can be triggered in a timely fashion.
• Communicate, plan, prioritise and deliver submission documents according to company targets and submission requirements; liase with stakeholders using the most effective means of communication; presenting information in an optimal format and level of information for that audience.
• Ensure all actions taken within role follow applicable SOPs and IG's so that high quality delivery of outputs and compliance is maintained.
• Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.
• Champion and /or participate in continuous improvement efforts related to business practices and tools utilized within role.
• For deliverables in scope, support responses to inquiries from Pfizer colleagues in response to inspection activities and regulatory agency questions.
• Knowledge of global/regional regulatory regulations and guidelines pertaining to labeling especially clinical submissions and demonstrated ability to decipher and understand implications of label changes both pending, approved and historical across document types and geographical regions/ countries.
• Demonstrated ability to understand, analyse and propose information into local labeling such as the LPD and Patient information and ability to logically review any impact on other sections of the same documentation.
• Utilize regulatory expertise to review, develop and deliver core-labelling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice from others when appropriate.
• Engage in necessary labelling team meetings to discuss any decisions for not making any label updates or discuss any findings of meaningful differences for registration types specific to USPIs, CRP-SmPCs and MRP/DCP-SmPCs as necessary
• Employ a consistent approach to the content of labelling documents assuring that governing SOPs and IG's are followed and external regulations are met.
• Ensure that decisions taken for labeling are accurately captured and communicated to appropriate stakeholders so that local and regional submission activities can be triggered in a timely fashion.
• Communicate, plan, prioritise and deliver submission documents according to company targets and submission requirements; liase with stakeholders using the most effective means of communication; presenting information in an optimal format and level of information for that audience.
• Ensure all actions taken within role follow applicable SOPs and IG's so that high quality delivery of outputs and compliance is maintained.
• Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.
• Champion and /or participate in continuous improvement efforts related to business practices and tools utilized within role.
• For deliverables in scope, support responses to inquiries from Pfizer colleagues in response to inspection activities and regulatory agency questions.
• Knowledge of global/regional regulatory regulations and guidelines pertaining to labeling especially clinical submissions and demonstrated ability to decipher and understand implications of label changes both pending, approved and historical across document types and geographical regions/ countries.
• Demonstrated ability to understand, analyse and propose information into local labeling such as the LPD and Patient information and ability to logically review any impact on other sections of the same documentation.
Continuous improvement, Fashion, Compliance, Content, Presenting, Support, Regulatory, Manager
2011 - 2011
job
Regulatory Labelling Manager
Norgine Pharmaceutical Limited.
Duties: General:
Responsible for the management of the Labelling Committee and any associated activities, ensuring that high quality documentation is prepared for safety submissions (variations, PSURs etc), liasing with relevant departments to ensure regulatory requirements for these submissions are met and managing the processes through which safety-related regulatory activities are planned, agreed and progressed.
Core Responsibilities:
To organise and manage the Labelling Committee and provide regulatory advice on safety-related matters under discussion.
To disseminate decisions made at the Labelling Committee meetings, ensuring all stakeholders are kept informed
To ensure high quality documentation is prepared for safety-related regulatory submissions, following current best practice standards.
To liase independently with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met.
To maintain product labelling for all markets in cooperation with local regulatory and commercial contacts
To maintain the Company Core Data Sheet (CCDS) for all products, and track local variances
To manage global SmPC variations, providing high-quality documentation to the appropriate Regulatory Affairs personnel, tracking submissions and approvals and ensuring all stakeholders are notified of any approved changes to SmPCs
To collate and manage the regulatory input into PSURs/ASRs and maintain the Regulatory PSUR/ASR Calendar, thus ensuring all PSUR/ASR Regulatory Data documents are completed on schedule and all PSURs/ASRs are submitted on time, according to compliance regulations
To participate as appropriate in project teams
To identify and provide information for incorporation in the Regulatory databases as appropriate
To provide information on expenditure against budget for inclusion in monthly financial reports
To provide leadership and guidance to Regulatory Associates and Labelling Administrators ensuring that they maintain the paper and electronic filing systems for their products/countries, following Records Retention Procedures Core Responsibilities.
Responsible for the management of the Labelling Committee and any associated activities, ensuring that high quality documentation is prepared for safety submissions (variations, PSURs etc), liasing with relevant departments to ensure regulatory requirements for these submissions are met and managing the processes through which safety-related regulatory activities are planned, agreed and progressed.
Core Responsibilities:
To organise and manage the Labelling Committee and provide regulatory advice on safety-related matters under discussion.
To disseminate decisions made at the Labelling Committee meetings, ensuring all stakeholders are kept informed
To ensure high quality documentation is prepared for safety-related regulatory submissions, following current best practice standards.
To liase independently with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met.
To maintain product labelling for all markets in cooperation with local regulatory and commercial contacts
To maintain the Company Core Data Sheet (CCDS) for all products, and track local variances
To manage global SmPC variations, providing high-quality documentation to the appropriate Regulatory Affairs personnel, tracking submissions and approvals and ensuring all stakeholders are notified of any approved changes to SmPCs
To collate and manage the regulatory input into PSURs/ASRs and maintain the Regulatory PSUR/ASR Calendar, thus ensuring all PSUR/ASR Regulatory Data documents are completed on schedule and all PSURs/ASRs are submitted on time, according to compliance regulations
To participate as appropriate in project teams
To identify and provide information for incorporation in the Regulatory databases as appropriate
To provide information on expenditure against budget for inclusion in monthly financial reports
To provide leadership and guidance to Regulatory Associates and Labelling Administrators ensuring that they maintain the paper and electronic filing systems for their products/countries, following Records Retention Procedures Core Responsibilities.
Budget, Leadership, Management, Compliance, Safety, Regulatory Affairs, Regulatory, Retention, Processes, Manager
2008 - 2011
freelance
Consultant
PAREXEL International Uxbridge.
Duties: General:
Consulting
- Comprehensive understanding of the organization's consulting models and methodologies.
- Good understanding of business context within the pharmaceutical, biotechnology, medical device or other regulated healthcare industries.
- Ensures the timely performance of work within project scope and objectives with an understanding of issue which impact project profitability.
- Works with clients to identify technical and process issues
Client Relationships & Demand for Services
- Is proactive in assessing client needs and developing processes and solutions to address issues before they become significant problems.
- Understanding of the consulting role and ability to interact at multiple levels within the client organization.
- Alert to and identifies opportunities for follow-on business.
- Interactions result in clients expressing satisfaction with service provided and occasionally result in additional business or referrals.
Project Execution & Success
- Works within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts
- Demonstrates follow through and appreciation for project deadlines to meet project objectives.
- Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action.
- Uses information from previous projects or other work with the client to make business decisions.
- Provides guidance to project team members, mostly in technical or process areas.
Specific
- Function as Regulatory Project Manager on assigned projects and mentor other Regulatory Project Managers, Co-ordinate and manage flow of information, document client and agency contacts. Track project progress (in collaboration with Project Management Assistant) including time spent to perform project tasks with respect to the budgeted hours to forecasting, and identify and solve problems in a team-oriented environment.
-Reviews and prepares regulatory submissions in the following regions: EU, Russia, Africa &Middle East, Asia, APAC - (Australia, Hong Kong, South Korea, and Taiwan) Latin America - (Argentina, Brazil and Chile) regions.
- Design and complete regulatory deliverables (clinical trial applications for National Competent Authorities and Ethics Committees', Marketing applications, etc) for assigned projects; interface with clients as appropriate during process.
- Conduct critical reviews of key technical documents (including non-clinical and clinical development plans, protocols and reports, pre-existing regulatory dossiers and related documentation) aiming to ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents and ease of review.
- Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and disciplines areas relevant to assigned projects and advise clients and internal staff accordingly. Liaise with regulatory authorities.
Consulting
- Comprehensive understanding of the organization's consulting models and methodologies.
- Good understanding of business context within the pharmaceutical, biotechnology, medical device or other regulated healthcare industries.
- Ensures the timely performance of work within project scope and objectives with an understanding of issue which impact project profitability.
- Works with clients to identify technical and process issues
Client Relationships & Demand for Services
- Is proactive in assessing client needs and developing processes and solutions to address issues before they become significant problems.
- Understanding of the consulting role and ability to interact at multiple levels within the client organization.
- Alert to and identifies opportunities for follow-on business.
- Interactions result in clients expressing satisfaction with service provided and occasionally result in additional business or referrals.
Project Execution & Success
- Works within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts
- Demonstrates follow through and appreciation for project deadlines to meet project objectives.
- Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action.
- Uses information from previous projects or other work with the client to make business decisions.
- Provides guidance to project team members, mostly in technical or process areas.
Specific
- Function as Regulatory Project Manager on assigned projects and mentor other Regulatory Project Managers, Co-ordinate and manage flow of information, document client and agency contacts. Track project progress (in collaboration with Project Management Assistant) including time spent to perform project tasks with respect to the budgeted hours to forecasting, and identify and solve problems in a team-oriented environment.
-Reviews and prepares regulatory submissions in the following regions: EU, Russia, Africa &Middle East, Asia, APAC - (Australia, Hong Kong, South Korea, and Taiwan) Latin America - (Argentina, Brazil and Chile) regions.
- Design and complete regulatory deliverables (clinical trial applications for National Competent Authorities and Ethics Committees', Marketing applications, etc) for assigned projects; interface with clients as appropriate during process.
- Conduct critical reviews of key technical documents (including non-clinical and clinical development plans, protocols and reports, pre-existing regulatory dossiers and related documentation) aiming to ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents and ease of review.
- Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and disciplines areas relevant to assigned projects and advise clients and internal staff accordingly. Liaise with regulatory authorities.
Service, Manager, Asia, Processes, Development, Medical device, Regulatory, Biotechnology, Compliance, Marketing, Pharmaceutical, Consulting, Management, Mentor, Forecasting, Project Manager, Project Management, Design
2002 - 2006
job
Research Associate - Clinical Biochemistry
Royal London Hospital.
Duties: Working in the laboratory as part of a team, undertaking routine pathology work and providing general laboratory assistance. Core duties involve specimen reception, centrifuging and a variety of other laboratory duties. Assisting in the handling, preparation and distribution of reagents, other materials, consumables and equipment. Participating in carrying out various types of Biochemistry test using immuno analyzer, Olympus and dimension equipment. Participating in registration of patient Information/Samples onto the Patient Administration System (PAS), quality control and other laboratory database.
Other main duties include:
1. Liaise, internally and externally, with a range of professionals in order to obtain the information required for completion of multiple internal and external Ethics, Research and Development, Imaging forms in relation to each individual clinical trial.
2. Explain to this range of professionals what each clinical trial involves, how their area is affected by any particular trial and why certain documentation is required.
3. Plan points 1 and 2 in such a manner so as to facilitate trials starting on time, according to the timeframe set and ensure that all parties are working to the correct version of the research documentation.
4. Judge which documents are required for any particular trial and take whatever proactive steps are necessary to obtain them
5. Ensure that all trials in the Department are run according to the EU Directive and in accordance with ICH Good Clinical Practice.
6. Disseminate information received regarding Serious Unsuspected Adverse Reactions (SUSAR) to all internal and external parties within 24 hours as required by protocols and co-ordinate the reporting of the follow-up investigation.
7. Co-ordinate the process monitoring by external pharmaceutical companies of their particular trial currently being run correctly.
8. Collate clinical trial results and assist in their write-up as the trials progress and come to a close.
9. Format research papers for publication ensuring that the particular requirements of each different journal are met and use the Internet to check references are accurate.
10. Entering of clinical trial data onto the oracle clinical database and dealing with all discrepancies.
Other main duties include:
1. Liaise, internally and externally, with a range of professionals in order to obtain the information required for completion of multiple internal and external Ethics, Research and Development, Imaging forms in relation to each individual clinical trial.
2. Explain to this range of professionals what each clinical trial involves, how their area is affected by any particular trial and why certain documentation is required.
3. Plan points 1 and 2 in such a manner so as to facilitate trials starting on time, according to the timeframe set and ensure that all parties are working to the correct version of the research documentation.
4. Judge which documents are required for any particular trial and take whatever proactive steps are necessary to obtain them
5. Ensure that all trials in the Department are run according to the EU Directive and in accordance with ICH Good Clinical Practice.
6. Disseminate information received regarding Serious Unsuspected Adverse Reactions (SUSAR) to all internal and external parties within 24 hours as required by protocols and co-ordinate the reporting of the follow-up investigation.
7. Co-ordinate the process monitoring by external pharmaceutical companies of their particular trial currently being run correctly.
8. Collate clinical trial results and assist in their write-up as the trials progress and come to a close.
9. Format research papers for publication ensuring that the particular requirements of each different journal are met and use the Internet to check references are accurate.
10. Entering of clinical trial data onto the oracle clinical database and dealing with all discrepancies.
Administration, Oracle, Research, Database, Laboratory, Pharmaceutical, Test, Reception, Monitoring, Development, Internet, UP
My education
University of Uyo
M Pharm, N/a
M Pharm, N/a
Universal College
N/a, Computer Studies
N/a, Computer Studies
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