Regulatory Affairs Contract - 6-12 months. Excellent Rates!!

Regulatory Manager - New Product Evaluation. Due Diligence, In-Licencing Products/BD. Are you already an experienced Regulatory Manager/Project Manager? If so, this is the Contract opportunity you have been waiting for. This Regulatory Affairs Team Lead is for a fast-growing Specialist Pharma Company in the Middlesex/Northwest London area; this organisation has a highly successful established product portfolio and is now expanding into new Therapeutic areas with the acquisition of New Products.

Reporting to the Vice President Regulatory Affairs, you will be responsible for applying extensive Regulatory knowledge and expertise to all Business Development (BD) activities, producing Due Diligence reports and Regulatory Strategies that optimise New Product Development plans for In-Licenced Products, and for support effective transitional arrangements for In-Licenced and Out-Licensed Products. You will provide expert advice on BD activity to Key Stakeholders - Therapy Heads and Quality Teams etc. You will establish an excellent working relationship with Regulatory CMC/Manufacturing, Labelling and Life-cycle management teams, you will possess good influencing skills and leadership qualities. Budget responsibility.

Technically, you will have good working knowledge and experience of Late Phase Development, Registrations and Post marketing activity; Development/CTA's, CTD/Dossiers for MAA's (ideally, all Modules 1 to 5); National Submissions/MRP, DCP and Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. Your geographic scope will be Pan-European and some International territories.

Circa £100 per hour net. Middlesex North-West London location. but some flexible working arrangements.

Candidates from a Pharma or Biologics background in European & International Regulatory Affairs with over 8+ years' experience, and good mentoring skills should be suitable for this position. You will possess good commercial awareness, a solid understanding of how the business works, and possess 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 0203 695 9477/07447 977 330 or by clicking Apply Now.