Regulatory Affairs Director / Advanced Therapies / Lead a Team / Development & Strategy
- Experience Level
- Senior Management
Director Regulatory Affairs – Advanced Therapies. Advanced Therapies expert. Regulatory Development & Strategy and Team Leadership in Clinical-stage Development. ADTHER, Cell and Gene Therapy focus. Top Consultancy in Essex!!
The Regulatory Affairs Director will be responsible for expert advice within Advanced Therapy Products, particularly pertaining to Clinical/Development – Phases I to III. Team Leadership skills are desirable for this role. This Consultancy provides high quality and competitively priced services to the Biotech and Biopharmaceutical industries hence there is a certain amount of Client-facing activity along with the management of the team and overseeing consultancy projects. Full Regulatory Pipeline exposure is required from Clinical/Development, through to Registrations and Post marketing. The geographic scope of this role is Pan-European. Good working knowledge of Biologics/ATMP’s is essential. This role reports to the Technical Director.
Your responsibilities will include: Project Leading & Advising on European Regulatory Affairs Strategy, Tactics and Implementation!! Technically, you will have good working knowledge and experience of: 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); 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.
Strong 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. 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 European Regulatory Affairs with over 7+ 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 email@example.com, or submit an application by clicking Apply Now.
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