UK Regulatory Affairs Manager / Specialist Pharma

Location
Sussex
Salary
Competitive
Posted
29 Apr 2021
Closes
29 May 2021
Ref
KnhUmFdsiWxm
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Manager, UK Regulatory Affairs!! Project Manage and Lead UK Submissions - Biologics and Pharma Products, but no prior Biotech product experience is required provided there is good UK Affiliate working knowledge. Strong Labelling experience an advantage; CMC and non/CMC combination. A great salary package offered to the right candidate.

Are you a UK Regulatory Project Manager or top-end Senior Associate with 3-5+ years' experience, adept in UK Regulatory Strategy and 'hands-on' Regulatory activity? If so, this is the opportunity you have been waiting for!!

Reporting to The Head of Regulatory Affairs, you will Project Lead, be Proactive & Advise on UK Regulatory Affairs. Technically, you will have good working knowledge and experience of: New Registrations and Life-cycle management: 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. Sunset Clauses. BROMI Applications. Past Scientific Advice meetings with the MHRA would be ideal.

Candidates from a Pharma, Biotech or Generics background, in UK Regulatory Affairs Development & Strategy and Project Management/Leadership with approximately 4-6+ year's+ solid experience, should be suitable for this position.

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