Regulatory Affairs Manager - OTC/Consumer Healthcare.

Are you already a Regulatory Project Manager/or experienced Principal/Senior Regulatory Associate, ready to take the step-up to Manager? If so, this could be the opportunity you have been waiting for!!

This Manager, Regulatory Affairs OTC, is focused on Registrations and Lifecycle and is for a fast-growing Specialist Pharma Company in the Middlesex/Northwest London area which now under exciting new management; this organisation has a successful established product portfolio and is expanding into new Therapeutic areas.

You will be required to mentor Regulatory Executives, and Project Lead and Manage. You will be responsible for the Registrations and Lifecycle of Products, and the implementation of Global Regulatory Strategy to maintain the organisation's existing product licences, and integrate newly approved products into the portfolio.

Strategic planning and implantation. Compliance and support of inspections and audits.

Management of overseas Affiliates and other Partners. Liaison with appropriate Regulatory Authorities. Operate within multi-functional teams.

Technically, you will have good working knowledge and experience of Registrations and Post marketing activity in OTC Products, and some Development experience would be beneficial: Lifecycle 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 Regulatory Lifecycle management with over 6-7 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.

A salary of circa £70,000 basic, 15% bonus and good benefits are on offer, as is hybrid working arrangements in the context of a Northwest London location.

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.