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Brenda Ijeoma BSc, MRPharmS
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I'm offering
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United Kingdom
Language
English
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My experience
2018 - ?
freelance
CMC Development/Biopharm BREXIT Regulatory Contractor
GSK.
DUTIES:
• Established process for how CMC BREXIT substantial amendments will be created, published and handed off for both small molecules and biopharma products and communicating this to the wider group
• Input in submission strategy for substantial amendment for each trial and creation of tracker to manage this
• Liaison/main point of contact for all CMC BREXIT-related development and biopharm substantial amendments
• Main point of contact for all CRO interaction regarding CMC BREXIT substantial amendments
• Creation of template for potential RtQs and liaising with both internal and external stakeholders to ensure these are created and handed off within agreed timelines.
• Ensuring that all necessary docbases are completed in respect of these submissions
• Training and bring up to speed additional contractor who came onto the project
• Established process for how CMC BREXIT substantial amendments will be created, published and handed off for both small molecules and biopharma products and communicating this to the wider group
• Input in submission strategy for substantial amendment for each trial and creation of tracker to manage this
• Liaison/main point of contact for all CMC BREXIT-related development and biopharm substantial amendments
• Main point of contact for all CRO interaction regarding CMC BREXIT substantial amendments
• Creation of template for potential RtQs and liaising with both internal and external stakeholders to ensure these are created and handed off within agreed timelines.
• Ensuring that all necessary docbases are completed in respect of these submissions
• Training and bring up to speed additional contractor who came onto the project
Training, Development, Cro, Regulatory, UP
2017 - 2018
freelance
Senior CMC Contractor - Global Regulatory Affairs
Amgen Ltd.
DUTIES:
• Product lead/main contact for biosimilar support in the creation of MAA core packages, associated country specific documents, CTA and variation packages for EU and emerging markets
• Mentor, manage and support less experienced associates in the creation of MAA packages; act as point of contact and support for out-sourced activities
• Liaise with internal stakeholders in the preparation of packages including discussion of realistic timelines and components required
• Product liaison for several contract manufacturers in order to acquire documentation required for submissions
• Product lead/main contact for biosimilar support in the creation of MAA core packages, associated country specific documents, CTA and variation packages for EU and emerging markets
• Mentor, manage and support less experienced associates in the creation of MAA packages; act as point of contact and support for out-sourced activities
• Liaise with internal stakeholders in the preparation of packages including discussion of realistic timelines and components required
• Product liaison for several contract manufacturers in order to acquire documentation required for submissions
Mentor, Less, Support, Regulatory Affairs, Regulatory
2017 - 2017
freelance
CMC Contractor - Global Regulatory Affairs
Eisai Co. Limited.
DUTIES:
• Support a manufacturing compliance project for Eisai products with specific product responsibilities.
• Lead creation and compilation of submission documents (Module 3 for Type IA and Type IB licence variations)
• Supports regulatory strategy and manages timelines to meet project needs.
• Interacts with internal and external stakeholders regarding CMC regulatory issues
• Support a manufacturing compliance project for Eisai products with specific product responsibilities.
• Lead creation and compilation of submission documents (Module 3 for Type IA and Type IB licence variations)
• Supports regulatory strategy and manages timelines to meet project needs.
• Interacts with internal and external stakeholders regarding CMC regulatory issues
Compliance, Support, Regulatory Affairs, Regulatory
2014 - 2015
job
Pre-registration Pharmacist
The Princess Alexandra Hospital.
Pre-registration programme which includes training and experience under varied rotations
ROTATIONS:
• Dispensary - Dispensing items and final check of dispensed in-patient orders
• Clinical Audit - Undertaking an audit with presentation of findings to colleagues/doctors
• Wards - Completing drug histories and learning how to clinically check a drug chart
• Med Info - Taking/resolving queries from colleagues/patients using evidence based data
• Technical Services Unit - Preparation of chemotherapy products within a sterile environment
• Community Pharmacy - Working in Tescos pharmacy; answering queries on OTC medicines and other services available
ROTATIONS:
• Dispensary - Dispensing items and final check of dispensed in-patient orders
• Clinical Audit - Undertaking an audit with presentation of findings to colleagues/doctors
• Wards - Completing drug histories and learning how to clinically check a drug chart
• Med Info - Taking/resolving queries from colleagues/patients using evidence based data
• Technical Services Unit - Preparation of chemotherapy products within a sterile environment
• Community Pharmacy - Working in Tescos pharmacy; answering queries on OTC medicines and other services available
Training, Audit, Community, Audit, Pharmacist
2005 - 2010
job
changed roles from a registration associate to a quality auditor
Merck Sharp & Dohme (MSD Ltd).
Quality Auditor: This role was within the QA department for Clinical Trial supplies
DUTIES:
• Checking that what is packaged for clinical supplies is compliant with its regulatory filing and GMP practices
• Capturing any deviations from GMP in the form of a CAFU.
• Investigating complaints and temperature excursions of supplies during transit or at the clinical site.
• Participating in projects that help to improve processes and procedures
Registration Associate: This role was within the UK/IRE subsidiary of MSD.
DUTIES:
• Maintaining existing EU and national licenses, filing variations and renewals with both the MHRA and IMB
• Preparing new CTA applications and substantial amendments and responding to remarks made by the agency.
• Participating in cross functional teams to ensure expedited launches of new products and the timely implementation of changes to the prescribing information and packaging of in-line products.
• Advising on regulatory issues to colleagues in the local marketing, medical information and clinical departments and the US and EU Regulatory Affairs offices.
DUTIES:
• Checking that what is packaged for clinical supplies is compliant with its regulatory filing and GMP practices
• Capturing any deviations from GMP in the form of a CAFU.
• Investigating complaints and temperature excursions of supplies during transit or at the clinical site.
• Participating in projects that help to improve processes and procedures
Registration Associate: This role was within the UK/IRE subsidiary of MSD.
DUTIES:
• Maintaining existing EU and national licenses, filing variations and renewals with both the MHRA and IMB
• Preparing new CTA applications and substantial amendments and responding to remarks made by the agency.
• Participating in cross functional teams to ensure expedited launches of new products and the timely implementation of changes to the prescribing information and packaging of in-line products.
• Advising on regulatory issues to colleagues in the local marketing, medical information and clinical departments and the US and EU Regulatory Affairs offices.
Marketing, Packaging, QA, Implementation, Gmp, Regulatory Affairs, Regulatory, Processes
2004 - 2005
job
UK Regulatory Executive
Pfizer Consumer Healthcare.
DUTIES:
• Preparing, submitting and responding to RSIs for renewal and variation applications which involve the review of supporting data to ensure that it complies with local regulatory requirements.
• Helping to ensure timely and accurate implementation of variations, SmPCs, PIL and packaging amendments through regular liaison and correspondence with other departments
• Preparing, submitting and responding to RSIs for renewal and variation applications which involve the review of supporting data to ensure that it complies with local regulatory requirements.
• Helping to ensure timely and accurate implementation of variations, SmPCs, PIL and packaging amendments through regular liaison and correspondence with other departments
Packaging, It, Implementation, Regulatory
1999 - 2002
job
senior scientific assessor
Medicines Control Agency.
DUTIES:
• Pharmaceutical/scientific assessment and overall approval of parallel import product licence applications and product information in order to comply with the requirements set by current regulatory guidelines.
• Pharmaceutical/scientific assessment and overall approval of parallel import product licence applications and product information in order to comply with the requirements set by current regulatory guidelines.
Pharmaceutical, Regulatory, Assessment
My education
University of Hertfordshire
N/a, Pharmacy MPharm
N/a, Pharmacy MPharm
University of London
BSc, Biochemistry
BSc, Biochemistry
Camden School For Girls
Secondary, N/a
Secondary, N/a
Harvington School For Girls
N/a, N/a
N/a, N/a
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