Director Regulatory Affairs CMC / Development & Strategy / Team Management / CMC expert
- Contract Type
Director Regulatory Affairs CMC. Line management of a Team and Matrix Team based Leadership. Client focus. Development CMC. Top Consultancy in Essex!!
The Director Regulatory Affairs CMC will provide advice and expertise on all Regulatory CMC activities: CTA’s/IND’s, IMPD writing, Module 3 writing, GAP Analysis, Due Diligence, Scientific Advice meetings and Regulatory Strategy. Leads CMC related discussions during scientific advice with National Agencies, the EMA, and FDA (including end of Phase 2 meetings).
Your responsibilities will include: Line Management, and Project Leading & Advising on European Regulatory CMC Strategy, Tactics and Implementation and overseeing a Team!! Ideally, you will have good working knowledge and experience of Clinical/Development Regulatory Affairs; Registrations and Post approval: CTA's, IND’s, IMPDs (writing), 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 – writing Modules 2.3 and 3); 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.
Adept in Regulatory Affairs CMC 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 CMC with over 10 year's experience, Team management skills and good EU Regulatory Affairs CMC 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 firstname.lastname@example.org, or submit an application by clicking Apply Now.