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Regulatory Affairs Specialist GlaxoSmithkline

AKPENE TETTEH , Accra, Ghana


Experience

5 - 9 years

Other titles

regulatory affairs manager project manager consultant

Skills

Regulatory Affairs Agile project management ISO 9001 quality management Governance Risk and Compliance Compliance + 1 more

I'm offering

I am an Entrepreneur, Compliance and quality focused regulatory affairs professional with cross/multicultural regulatory experience and expertise in Project Management spanning 8years experience within the pharmaceutical industry. Specialist in Regulating Drugs, Biological products, Food, Medical devices, Cosmetics and Household Chemical and devices. Proactive team player with knowledgeable regulatory expertise across West and Central African countries. And familiar with the EU, US and Canada regulatory processes.

Africa, which is bedevilled with varieties of tropical diseases and one of the highest consumer of pharmaceutical drugs unfortunately has no or inadequate policy on drug development, manufacturing, monitoring and distribution within most African countries, which Ghana is not an exception. I therefore aim to build upon my current expertise in Regulatory Affairs and in Research and Development of new products to support my region and world at large.

Below are some of my skills:

• Expert in ICH CTD dossier review

• Experience with registration of over 100 drugs including vaccines for GlaxoSmithKline in Africa

• I have worked on the registration of New Chemical Entities / Generic products and the Management of Product Life Cycle for GSK (Rx, Vx, Cx, and Medical Device) and other 3rd parties such as Aspen, UCB, DRL, Ipca, and ViiV. And maintained over 150 product licenses.

• Promptly relay Regulatory Intelligence to team members and superiors to avoid non-compliance issues with the state

• Investigation and research – Volunteered to led in investigating and sourcing out suspected parallel / fake imported GSK products in Ghana, saving the company £1200 and more, a fee for the services of an external counsel on this task and this was a success story

• Accurate data entry and maintenance of GSK Global Regulatory Databases

• Project management – successfully completed many projects

• Quality Management System – involved in Level 1, 2, and 3 audits

• Monitoring / Coaching - Worked across boundaries to support my colleagues (UK, USA, India, South Africa, Nigeria, Cote d’ Ivoire, etc) in the interpretation of regulatory guidelines and in brainstorming on the ways of working on key projects.

Markets

United Kingdom

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Language

English
Fluently

Ready for

  Smaller project
  Larger project
  Ongoing relation / part-time
  Full time contractor

Available

Typically available right away



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