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Job Details

Associate Director Regulatory Strategy / Oncology - top Biopharma

Company: Turner Regulatory
Location: Berkshire
Reference: 10065-1
Closing Date: 31 Aug 17
Type: Permanent
Salary (£): 80,000 - 100,000
Benefits: Car allowance, good bonus and leading benfits

Job Summary:

Associate Director, Regulatory Strategy. Oncology experience essential, as is EMA liaison, and working knowledge of taking a product through Phase III to an MAA via Centralised Procedure.

Requirements:

Associate Director, Oncology for a top Biopharma in a great location!! Oncology experience is essential along with new MAA's via Centralised Procedure.

Are you a Regulatory Manager or Senior Manager, adept in European Regulatory Affairs Strategy ready to take the step-up to Associate Director? If so, this is the opportunity you have been waiting for. This role is for a fast-growing and highly successful Biopharma in Berkshire with some of the most successful worldwide products. The role is focused on Late Phase Strategy and new MAA's for a Portfolio of Oncology Products. High-level Project Management: Project Lead & Advise on European Regulatory Affairs Strategy within the Oncology Portfolio!! Technically, you will have good working knowledge and experience of: Late Phase Development Regulatory Affairs leading to new MAA registrations and Post approval: CTD/Dossiers for MAA's; Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's.

You will be adept in Regulatory Strategy & Tactics and have good experience in dealing with Affiliates throughout the EU and beyond. Ideally, you will have experience in taking products thought Late Phase (III), through to successful Registrations and Post marketing. You will be required to interface with Commercial Teams and will operate as the primary interface with European Affiliates for the Portfolio of Products within this Therapeutic Area. Close EMA and other Health Authority liaison. You will possess good commercial awareness and an excellent eye for detail.

Candidates from a Biopharma, Pharma, or perhaps a CRO background in European Regulatory Affairs, fitting the criteria, and with approximately 7-10+ year's 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: £75,000-£90,000, car allowance, good bonus and leading benefits. Convenient Berkshire location. A certain amount of Travel will 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, by Email julian@turnerregulatory.com, or submit an application by clicking Apply Now.

 

 

Apply for this job: Associate Director Regulatory Strategy / Oncology - top Biopharma

Contact Information:

Address:  Head Office
71-75 Shelton Street
Covent Garden
WC2H 9JQ
England
Tel:  0203 695 9477
Website:  Visit Our Web Site

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