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Job Details

Manager, Regulatory Strategy - Europe - top Biopharma

Company: Turner Regulatory
Location: London
Reference: 10084-3
Closing Date: 29 Sep 17
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits: Bonus and good benefits

Job Summary:

Regulatory Affairs Manager; Biopharma; Regulatory Strategy & Development; European focus; Phases I to III, MAA's, Centralised Procedure


Regulatory Affairs Manager, for a top Biopharma in a superb Central London location!! Regulatory Strategy and ‘hands-on’ Development experience is essential along with new MAA’s via Centralised Procedure. Are you a Regulatory 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 Central London with an outstanding pipeline in rare diseases. The role is focused on Early and Late Phase Strategy and new MAA’s for a number of Niche Products.

This company is very patient-focused and has a great collegiate atmosphere; this is an autonomous role, and is a great place to learn and enhance your Regulatory Affairs career.

High-level Project Management & Leading – Product Leader: Project Lead & Advise on European Regulatory Affairs Strategy within the given Portfolio!! Technically, you will have good working knowledge and experience of: Early & Late Phase Development Regulatory Affairs leading to new MAA registrations via Centralised Procedure: CTD/Dossiers for MAA's; Centralised Procedure; Regulatory Strategy, Scientific Advice meetings and PIP’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 Early (I and II) and Late Phase (III), through to successful Registration. 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/Consultancy background in European Regulatory Affairs, fitting the criteria, and with approximately 6-8 year’s experience, should be suitable for this position.

Superb organisation – a top Biopharma employer with outstanding products and very desirable to have on your CV. A very competitive salary package is on offer for the right candidate. Convenient London 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 the number provided, by Email, or submit an application by clicking Apply Now.

Apply for this job: Manager, Regulatory Strategy - Europe - top Biopharma

Contact Information:

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

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