Senior Regulatory Affairs Manager / Top Biopharma / Team Lead / Full Regulatory Pipeline exposure / Centralised Procedure

Senior Regulatory Affairs Manager / Top Biopharma / Line Manage

Regulatory Strategy, Regulatory Development, New Drug Applications & Product Life-cycle maintenance across European and some International Markets. MAA’s via Centralised Procedure. PIP’s, Scientific Advice and Orphan Drugs.

Top Biopharma in 2 locations with some flexible working!!

Line Manage and mentor a Team and Project Lead.

This role is focused on the Virology Portfolio; this Therapeutic Area experience is welcome but not necessarily essential.

Regulatory Strategy, Line Managing, Project Managing and Support across Europe and some International regions. Are you a Regulatory Project Manager/Manager, adept in European & International Regulatory Strategy and ‘hands-on’ Regulatory activity? If so, this is the opportunity you have been waiting for. This Senior 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 Development, New Product Registrations and Post marketing.

Reporting to The Regulatory Director EU, 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: CTA’s and other Clinical/Development activity; 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. 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 Early & 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 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 10 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 some flexible 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.

 

Some Of Our Feedback

  • A fast-growing Biotech Company were struggling to find a Vice President, Global Regulatory Affairs and having engaged a major Executive Search firm in the USA had spent over 1 year looking for the right candidate without success. Within 8 weeks of requesting my help, we provided the company with 12 candidates, from which the ideal candidate was selected, who, over two years on, is still successfully operating within this role.

  • A leading Biopharma Company were looking for an Associate Director, Regulatory Strategy Team Lead for Emerging Markets, but had thus far failed to secure the right candidate. In fact, after 6 months of trying they’d only been able to secure an interview with one, less than ideal, candidate. Within 30 days of working with myself, a very suitable candidate was identified and started working for the company within 3 months. We provided the Biopharma Company with 11 excellent candidates to choose from.

  • A Pharmaceutical Company contacted me to find their new Head of Regulatory Affairs, to be based in a challenging location. Within 60 days of approaching me, after an intercontinental recruitment campaign, 6 candidates were identified and delivered. A suitable candidate was chosen and placed. The Company expressed their gratitude for having exceeded their expectations.

  • A newly created Vaccines organisation tasked Turner Regulatory Recruitment with finding a Head of Region, Senior Director, EU Regulatory Affairs. At the time, there were a number of Biotech/Vaccines companies seeking to fill similar positions; however, in spite of these challenging market conditions 13 candidates were identified and put forward from the ensuing short-listing process, one particular candidate was chosen, offered and accepted; this candidate is still happily in situ.

  • A well-established and commercially successful Biotech Company was having trouble in sourcing a Senior Director Regulatory CMC with a European/EMEA focus for their London Office. This organisation had been seeking to fill this role using numerous Agencies/Head-hunters for well over 6 months without success. Turner Regulatory Recruitment took a fresh and targeted approach to the role, identifying and delivering 8 excellent candidates. From the following interviewing process, not 1, but 2 candidates were offered, and both accepted.