Regulatory Affairs Director / Post Marketing / Dynamic Biopharma / West of London
- Contract Type
The Regulatory Affairs Director will be responsible high-level Project Managing & Leading, and supervision of a small Regulatory Team. This role focuses largely on Post-marketing/life-cycle maintenance activity – Type Ia, Ib and II Variations and Renewals – Geographic scope is European and International/Global – working knowledge of National Submissions/MRP, DCP and Centralised Procedure. Good all-round Regulatory Affairs experience is desired including Clinical/Development – Phases I to IV; Global exposure.
This Biopharma is a dynamic and ambitious organisation. The environment is fast-paced, and a good team fit with the existing Regulatory Staff is crucial to securing this position.
Your responsibilities will include: Project Leading & Advising on Regulatory Affairs Strategy, Tactics and Implementation. Technically, you will have good working knowledge and experience of: National Submissions/MRP, DCP and Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; in addition, Phases I to IV: Clinical/Development Regulatory Affairs; Registrations and Post approval: CTA's, IND’s, IMPD’s, IB’s, Protocols, updates/amendments and End of Trial Notifications/other Development Regulatory activity, CTD/Dossiers for MAA's (overseeing all Modules 1 to 5); Labelling, PIL's and SmPC's. PSUR’s. Scientific Advice meetings and PIP's.
Strong in Regulatory Affairs Strategy, Tactics and Implementation, you will have working knowledge of Regulatory Intelligence, and have attended Scientific Advice meetings with Regulatory Authorities. PIP’s and Orphan Drug exposure. Ideally, you will have experience in taking products through Late Phase, through to successful Registrations and Post marketing/Life-cycle maintenance. You will have experience across numerous Therapeutic Areas. You will possess good commercial awareness, a good understanding of how the business works, and how Regulatory matters can impact on ‘the bottom line’. You will have and an excellent eye for detail.
Candidates from a Pharma, Biopharma, or perhaps a CRO background, in Global Regulatory Affairs with over 10 year's experience and Project/Team management skills should be suitable for this position.
Highly competitive salary package. Desirable West of London/West Country location. 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 0203 69 9477/07447 977 330, or email@example.com, or submit an application by clicking Apply Now.
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