Associate Director, Regulatory Affairs / Biologic Products / Late

Associate Director, Regulatory Affairs. Biologic Products. Late Phase Development, Complex/New MAA's and Regulatory Life–cycle maintenance across European & International markets.

Regulatory 'hands–on' Project leading with some Strategy input.

Full Regulatory Pipeline role for a Top Biopharma in London. Flexible working is offered.

Regulatory Strategy and Project Leading across Europe. The role is focused on a Portfolio of Innovative Products in various stages of Development and Registration.

Are you a Senior Regulatory Manager or Project Manager, adept in European & International Regulatory Development and Life–cycle Management activity? If so, this is the opportunity you have been waiting for.

This Associate Director Regulatory Affairs role is for a fast–growing and highly successful Biopharma with a portfolio of 'cutting–edge' products based in a desirable area of Central/West London.

Reporting to The Senior Director, Regulatory Affairs, you will Project Lead & Advise on European & International Regulatory Affairs Strategy.

Technically, you will have good working knowledge and experience of: Development, New Registrations, Pre, and Post approval: Phase III CTA's and other Regulatory Development activity – IMPD's, IB's, Protocols, up–dates/amendments, and End of Trial Notifications; CTD/Dossiers for MAA's (overseeing all Modules 1–5); National Submissions/MRP, DCP and particularly Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's.

Ideally, you will have led/participated in Scientific Advice meetings with Regulatory Authorities and PIP's/PIP Waivers. Orphan Drugs/Rare Diseases.

You will collaborate closely with all other key Global Regulatory Affairs stakeholders, including other Global Regulatory Leads, Labelling, CMC, Regulatory Operations, other Regulatory Teams and Regulatory Affiliates, to ensure that all aspects of the European & International Strategy are observed and implemented.

You will be adept in Regulatory Strategy & Tactics and have good experience in dealing with Affiliates. Ideally, you will have experience of taking Products from Late Phase, through to successful New Registrations and Post marketing.

You will be required to interface with Commercial Teams and will operate as the primary interface with Affiliates across assigned Therapeutic Areas. You will possess good commercial awareness and an excellent eye for detail.

Candidates from a Biopharma background, in European & International Regulatory Affairs Strategy and Project Management/Leadership with 8 years+ solid experience including Development, MAA's and Life–cycle Management, should be suitable for this position.

Superb organisation – a top employer with outstanding products and very desirable to have on your CV. A very competitive salary package is on offer for the right candidate.

Desirable Central/West London location which is also convenient for those who live West of London and Berkshire. Flexible working is allowed. Some Travel may be required in this role.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on /, or by clicking Apply Now.