Top-end Regulatory Affairs Manager, or Senior Manager / Life-cycle Management / Strategy / European

Top-end Regulatory Affairs Manager or Senior Manager - Life-cycle Management - Strategy - European focus; Regulatory CMC knowledge desirable

Remote working anywhere in the UK or Europe permitted.

Are you already a Regulatory Manager/or experienced Regulatory Project Manager or Principal Regulatory Associate, ready to take the step-up to Manager? If so, this is the opportunity you have been waiting for. This Manager, Regulatory Life-cycle is for a fast-growing Specialist Pharma Company in the Middlesex/North West London area, although this role can operate from anywhere in the UK or Europe.

Product Portfolio Leader: this organisation has a highly successful established product portfolio and in recent years has expanded into new Therapeutic areas.

You will be required to mentor Regulatory Executives, establish the Strategy and Project Lead/Manage within a multi-functional environment. 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 and non-CMC combination; 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 background in European Regulatory Life-cycle management with over 5 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.