Regulatory Affairs Manager / Development, Registrations & Post Marketing / Project Management / Lead

Turner Regulatory
10 Oct 2018
15 Oct 2018
Contract Type
Full Time
Regulatory Affairs Manager. Team Management. Client focus; procedural Regulatory. Development, National Submissions & Centralised Procedure. Top Consultancy in Essex!!

The Regulatory Affairs Manager will provide advice on Registrations & Post Marketing activities: GAP Analysis, Due Diligence, Scientific Advice meetings and Regulatory Strategy. Knowledge of National Submissions/MRP, DCP and Centralised Procedure. The Regulatory Affairs Manager will assist the senior management team by providing leadership support to a team of internal consultants and their clients, and provide Regulatory advice to Business Development colleagues during bid defence.

Your responsibilities will include: Project Leading & Advising on European Regulatory Affairs Strategy, Tactics and Implementation and overseeing a small team!! Ideally, you will have good working knowledge and experience of 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); National Submissions/MRP, DCP and Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. PSUR’s. Scientific Advice meetings and PIP's. Orphan Drugs. Knowledge of CMC.

Adept in Regulatory Affairs Strategy, Tactics and Implementation, you will have working knowledge of Regulatory Intelligence, and have ideally attended Scientific Advice meetings with Regulatory Authorities. PIP’s and Orphan Drug exposure. Ideally, you will have experience in taking products through Early and Late Phase, through to successful Registrations and Post marketing. You will have experience across numerous Therapeutic Areas.

Candidates from a Pharma, Biopharma, or perhaps a CRO background, in European Regulatory Affairs with over 4 year's experience, Team management skills and good EU Regulatory Affairs experience should be suitable for this position.

Competitive salary package. This highly successful Consultancy is growing at a fast pace; a significant commercial opportunity. Desirable Essex 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 +44 203 695 9477/+44 7447 977 330, or, or submit an application by clicking Apply Now.

Similar jobs

Similar jobs