Manager Regulatory Affairs / ATMP’s / Cell Therapy/CAR-T / Development, MAA’s & Strategy

Manager Regulatory Affairs, Cell Therapy/CAR-T, Development, MAA’s & Strategy.

Manager Regulatory Affairs – ATMP/Cell Therapy – CAR-T, and Biologics; Strategy, Regulatory Development, New Drug Applications/MAA’s in European and some International Markets. 2 locations in the UK, but with some flexible working.

Strategy, CTA’s, PIP’s Orphan Drugs, Scientific Advice Meetings.

Superb and feast-growing 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 with some flexible working. ATMP working knowledge a strong preference, but strong Biologics may be acceptable.

Candidates from a Biotech or Biopharma background, in European Regulatory Affairs Development & Strategy and Project Management with ideally 5 years+ solid experience, should be suitable for this position. General Biologic experience is required and Gene or Cell Therapy/Advanced Therapy experience highly desirable. Rare Diseases & Orphan Drugs.

Regulatory Strategy and ‘Hands-on’, Project Managing across Europe. Are you a Regulatory Project Manager/Manager with approximately 5 years’ experience, adept in European Regulatory Strategy and ‘hands-on’ Regulatory Development activity? If so, this is the opportunity you have been waiting for.

This Regulatory Affairs Manager role is for a fast-growing and highly successful organisation dealing with ‘cutting-edge’ products; this role focuses primarily on a Cell Therapy CAR-T Products in early development, and the role is based in a choice of 2 locations (some flexible working). The position is focused on a variety of Regulatory activity, including Strategy and Development leading to New Product Registrations.

Project Lead, be Proactive & Advise on European & International Regulatory Affairs. Technically, you will have good working knowledge and experience of: Development and New Registrations: CTA’s, IND’s, VHP, IMPD’s, IB’s, Protocols, up-dates/amendments, End of Trial Notifications, and other Regulatory Development activity; Scientific Advice meetings, PIP’s & Orphan Drugs.

You will be adept in Regulatory Strategy & Tactics; Ideally, you will have experience of taking Products from Early & Late Phase, through to successful New Registration.

You will collaborate closely with all other key Global Regulatory Affairs stakeholders, in the USA and elsewhere to ensure that all aspects of the Regulatory Development Strategy are observed and implemented.

You may be required to interface with Commercial Teams and possess good commercial awareness and an excellent eye for detail.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on +44 203 695 9477/+44 1582 290 636; +44 7447 977 330, or julian@turnerregulatory.com, or submit an application 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.