SENIOR REGULATORY MANAGER – GLOBAL STRATEGY – mAb PRODUCTS
- Experience Level
Very rare Global and full Regulatory pipeline role!!! Manage a major Monoclonal Antibody Product!!
Senior Regulatory Affairs Manager, Biopharma; mAbs, Global & full Regulatory pipeline exposure– fast-growing Biopharma.
Regulatory Strategy, Project Management, Clinical/Development Regulatory, Registrations, and Life-cycle maintenance across Global Markets – European, USA, and International/ROW/Emerging Markets.
Fast-growing and successful Biopharma located North West of London/Hertfordshire!! Flexible working offered.
Regulatory Strategy and Project Leading - Global scope. Product launches.
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 successful Biopharma with a portfolio of ‘innovative’ products; this role will be based in a desirable area just North West of London. The role is focused on Clinical/Development, Registrations, and Post marketing/Life-cycle Management. Clinical, non-Clinical & CMC combination.
Reporting to The Associate Director, Regulatory Affairs, you will Project Lead & Advise on 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, in order to ensure that all aspects of the European Strategy is 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 5-8 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 North West of London location which is also convenient for those who live close to London in Berkshire, Hertfordshire, 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, firstname.lastname@example.org or by clicking Apply Now.
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