Associate Director, Regulatory Life-cycle Management / Specialist Pharma
5 days left
- Experience Level
- Senior Management
Associate Director, Regulatory Life-cycle Management. Are you already an Associate Director, a Senior Regulatory Manager/or experienced Manager/Project Manager, ready to take the step-up to Associate Director and manage a Team? If so, this is the opportunity you have been waiting for. This Associate Director, Regulatory Life-cycle is for a fast-growing Specialist Pharma Company in the Middlesex/North West London area; this organisation has a highly successful established product portfolio and expanding into new Therapeutic areas.
You will be required to manage a small team of 5/6 Regulatory Executives, and Project Lead and Manage hence previous Line Management and mentoring is required. You will be responsible for the Life-cycle Team and the implementation of Global Regulatory Strategy to maintain the organisation’s existing product licences, and to integrate newly approved products into the portfolio. Management of overseas Affiliates and other Partners. Liaison with appropriate Regulatory Authorities.
Technically, you will have good working knowledge and experience of Registrations and Post marketing activity and some Development experience would be beneficial: Life-cycle management; CMC; 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.
Candidates from a Pharma or Biologics background in European & International Regulatory Life-cycle management with over10 years’ experience, and good people managing 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 email@example.com
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