Contract Regulatory Affairs Manager / Top Biopharma / Pre- and Post-Approval / Antivirals / European Markets
Job Description
Regulatory Affairs Manager / Top Biopharma / Virology / European Markets
Regulatory Strategy, Regulatory Development, New Drug Applications & Product Life-cycle maintenance across European Markets. MAA’s via Centralised Procedure.
Top Biopharma in 2 locations with hybrid working!!
This role is focused on the Virology Portfolio; experience in Virology is welcome but not necessarily essential.
Regulatory Strategy, Project Managing and Support across Europe. Are you a Regulatory Project Manager or Junior Manager, adept in European Regulatory Strategy and ‘hands-on’ Regulatory activity? If so, this is the opportunity you have been waiting for. This Regulatory Manager role is for a fast-growing and highly successful Biopharma with a portfolio of ‘cutting-edge’ products; this role is based in 2 desirable locations, but some flexible working. Regulatory Strategy across New Product Registrations and Post marketing.
Reporting to The Regulatory Director, you will Project Lead & Advise on European Regulatory Affairs Strategy!! Technically, you will have good working knowledge and experience of: Development, New Registrations, Pre, and Post approval: CTD/Dossiers for MAA’s; 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 Orphan Drugs and PIP’s.
You will collaborate closely with all other key Global Regulatory Affairs stakeholders, including other Global Regulatory Leads, Labelling, CMC, Regulatory Operations, other Regulatory Teams and Regulatory Affiliates, to ensure that all aspects of the Regional Strategy are observed and implemented.
You will be adept in Regulatory Strategy & Tactics and have good experience in dealing with Affiliates. Ideally, you will have experience of taking Products from Pre-approval, through to successful New Registrations and Post marketing.
You will be required to interface with Commercial Teams and will operate as the primary interface with Affiliates across the assigned Therapeutic Area. You will possess good commercial awareness and an excellent eye for detail.
Candidates from a Biotech, Biopharma, Pharma or perhaps a CRO background, in European Regulatory Affairs Strategy and Project Management/Leadership with 6+ years solid experience, should be suitable for this position.
Superb organisation – a top employer with outstanding products and very desirable to have on your CV. A very competitive salary package is on offer for the right candidate.
2 desirable locations both North and West of London with hybrid working. 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 the number provided, or by email, or apply by clicking Apply Now.
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