Associate Director, UK Regulatory Affairs / Top Biopharma / Innovative
- Recruiter
- Turner Regulatory
- Location
-
London
South East EnglandUnited Kingdom
- Salary
- Competitive
- Posted
- 06 Apr 2021
- Closes
- 16 Apr 2021
- Job Title
- Associate Director
- Category
- Public Sector
- Contract Type
- Permanent
- Hours
- Full Time
Associate Director, UK Regulatory Affairs!! Working with the UK General Manager, you will operate as UK Regulatory Affairs Subject Matter Expert.
Are you a UK Senior Regulatory Project Manager/Senior Manager with 8+ years' experience, adept in UK Regulatory Strategy and 'hands–on' Regulatory activity? If so, this is the opportunity you have been waiting for!! Superb organisation – a top Biopharma employer with 'cutting–edge' Biopharma Products and very desirable to have on your CV.
Close relations with the MHRA are desirable as is Biopharma Product experience.
Regulatory Strategy and 'Hands–on', Project Managing in UK Affiliate Market. Operate within a matrix environment and multi–functional teams.
Reporting to The Regional Lead Regulatory Affairs, you will Project Lead, be Proactive & Advise on UK Regulatory Affairs. Technically, you will have good working knowledge and experience of: Development and New Registrations: CTA's, IMPD's, IB's, Protocols, up–dates/amendments, End of Trial Notifications, and other Regulatory Development activity; CTD/Dossiers for MAA's; National Submissions/MRP, DCP and Centralised Procedure. Post Marketing: Type Ia, Ib and II Variations, Renewals and Line Extensions; Labelling, PIL's and SmPC's. BROMI Applications. Scientific Advice meetings with the MHRA; PIP's & Orphan Drugs. Rare Diseases & Orphan Drugs.
You will be adept in Regulatory Strategy & Tactics and have good experience within a UK Affiliate. Ideally, you will have experience of taking Products from Early & Late Phase, through to successful New Registration and Post Marketing.
Candidates from a Biotech, Biopharma or Pharma background, in UK Regulatory Affairs Development & Strategy and Project Management/Leadership with approximately 8 year's+ solid experience, should be suitable for this position.
Are you a UK Senior Regulatory Project Manager/Senior Manager with 8+ years' experience, adept in UK Regulatory Strategy and 'hands–on' Regulatory activity? If so, this is the opportunity you have been waiting for!! Superb organisation – a top Biopharma employer with 'cutting–edge' Biopharma Products and very desirable to have on your CV.
Close relations with the MHRA are desirable as is Biopharma Product experience.
Regulatory Strategy and 'Hands–on', Project Managing in UK Affiliate Market. Operate within a matrix environment and multi–functional teams.
Reporting to The Regional Lead Regulatory Affairs, you will Project Lead, be Proactive & Advise on UK Regulatory Affairs. Technically, you will have good working knowledge and experience of: Development and New Registrations: CTA's, IMPD's, IB's, Protocols, up–dates/amendments, End of Trial Notifications, and other Regulatory Development activity; CTD/Dossiers for MAA's; National Submissions/MRP, DCP and Centralised Procedure. Post Marketing: Type Ia, Ib and II Variations, Renewals and Line Extensions; Labelling, PIL's and SmPC's. BROMI Applications. Scientific Advice meetings with the MHRA; PIP's & Orphan Drugs. Rare Diseases & Orphan Drugs.
You will be adept in Regulatory Strategy & Tactics and have good experience within a UK Affiliate. Ideally, you will have experience of taking Products from Early & Late Phase, through to successful New Registration and Post Marketing.
Candidates from a Biotech, Biopharma or Pharma background, in UK Regulatory Affairs Development & Strategy and Project Management/Leadership with approximately 8 year's+ solid experience, should be suitable for this position.