Senior Regulatory Affairs Manager / Top Biopharma / Major Biologic Product / EU & Global

21 Apr 2021
21 May 2021
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Senior Regulatory Affairs Manager, Biopharma; Major Biologic Product, EU & Global & full Regulatory pipeline exposure - Top Biopharma.

The role is focused on a Major Biologic Drug roll-out.

Regulatory Strategy, Project Management, Clinical/Development Regulatory, Registrations and Life-cycle maintenance across European and International Markets.

Fast-growing and successful Biopharma located in Central/West London!! Some flexible working offered.

Regulatory Strategy and Project Leading - EU & Global in scope. Development; Product launches and roll-out.

Are you a Regulatory Manager or Project Manager adept in Strategy and Global Development, Registrations and Life-cycle Management activity? If so, this is the opportunity you have been waiting for.

This Senior Regulatory Affairs Manager role is for a fast-growing and highly successful Biopharma with a portfolio of 'cutting-edge' products; this role will be based in a desirable area in Central/West London. The role is focused on: Clinical/Development, Registrations and Post marketing/Life-cycle Management. Clinical, non-Clinical & CMC combination.

Reporting to The Head of Regulatory Affairs, you will Project Lead & Advise on European & Global Regulatory Affairs Strategy and 'hands-on' activity. Product ownership of a recently approved major new drug.

Technically, you will have good working knowledge and experience of CTA's and other Development Regulatory, New Registrations; CTD/Dossiers for MAA's; National Submissions/MRP, DCP and particularly Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. PSUR's.

Ideally, you will have participated in Scientific Advice meetings with Regulatory Authorities and PIP's/PIP Waivers. Orphan Drugs/Rare Diseases.

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 European 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 Late Phase, 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 assigned Therapeutic Areas. You will possess good commercial awareness and an excellent eye for detail.

Candidates from a Biopharma or Pharma background, in Global, European & International Regulatory Affairs and Project Management/Leadership with 5-10 year's 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.

Desirable Central/West London location which is also convenient for those who live close to London in Berkshire, Surrey, and Buckinghamshire. 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 0203 695 9477/07447 977 330, or by clicking Apply Now.

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