Director Global Regulatory Affairs / Oncology / Strategy / Development / New MAA’s & Indications / Lifecycle

Director, Global Regulatory Affairs – Oncology. Biologic & Pharma Products. Leadership, Strategy, Clinical/Development, Complex/New MAA’s/New Indications and Regulatory Life-cycle management across European & International markets.

Hybrid Working offered.

Regulatory Strategy, Line Management and ‘hands-on’ Project Leading. Oncology portfolio.

Full Regulatory Pipeline role for a Top Biopharma. Hybrid working is offered.

Regulatory Strategy and Project Leading across Europe and International Markets. The role is focused on a Portfolio of Innovative Oncology Products in various stages of Development. Registration and Post Approval.

Are you an Associate Director or Director, adept in European & International Regulatory Strategy, Development and Life-cycle Management activity? If so, this is the opportunity you have been waiting for.

This Associate Director Regulatory Affairs role is for a fast-growing and highly successful Biopharma with a portfolio of ‘cutting-edge’ products based in two separate locations. Hybrid working is offered.

Reporting to The Executive Director/VP, Regulatory Affairs, you will Project Lead & Advise on European & International Regulatory Affairs Strategy for Oncology Products.

Technically, you will have good working knowledge and experience of: Development, New Registrations, Pre, and Post approval: Phases I-III: CTA’s and other Regulatory Development activity – IMPD’s, IB’s, Protocols, up-dates/amendments, and End of Trial Notifications; CTD/Dossiers for MAA’s (overseeing all Modules 1-5); National Submissions/MRP, DCP and particularly Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; PIL’s and SmPC’s. Labelling – Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI).

Ideally, you will have led/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 & International 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 assigned Therapeutic Areas. You will possess good commercial awareness and an excellent eye for detail.

Candidates from a Biopharma background, in European & International Regulatory Affairs Strategy and Project Management/Leadership with 10 years+ solid experience including Clinical/Development, MAA’s and Life-cycle Management, and Oncology 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 – £115,000-£120,000 basic, 20%-30% bonus, £8,700pa car allowance, generous RSU’s/LTI’s and other leading benefits.

The role can be based in one of two desirable locations in the Southeast; however, hybrid working is offered. 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, julian@turnerregulatory.com or 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.