Senior Regulatory Manager – EU – Branded Products
Are you already a Regulatory Manager/or experienced Regulatory Project Manager, ready to take the step-up to Senior Manager? If so, this is the opportunity you have been waiting for. This Senior Regulatory Manager, EU is for a fast-growing Pharma Company in the North of London area; this organisation has a highly successful established product portfolio and is expanding into new Therapeutic areas. The company is focused on both Branded and Generic Products.
You will be required to Project Lead and Manage. You will be responsible for the Pre- and Post-Registration and Post Marketing Team and the implementation of EU and 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 Pre-Registration & Development experience would be beneficial: CMC and non-CMC combination; CTD/Dossiers for MAA's (ideally, all Modules 1 to 5, particularly 1/2/3); National Submissions/MRP, DCP and Centralised Procedure; Post marketing/Life-cycle management: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. Your geographic scope will be Pan-European and possibly some International territories.
Candidates from a Pharma or Biologics background in European Pre- and Post-Registrations and Regulatory Life-cycle management with over 7 years’ experience, and good Project Management 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, firstname.lastname@example.org or by clicking Apply Now.