Senior Regulatory Manager, Innovative Medicines - Europe / Big Pharma / Hybrid Working

Hertfordshire/Essex Hybrid, UK
01 May 2024
31 May 2024
Regulatory Affairs
Full Time
Experienced (non-manager)
Senior Regulatory Manager, Innovative Medicines - Europe. Hybrid Working.

It is essential that the candidate possesses good Clinical Trail Application (CTA's) including CTR, experience, and is strong in European Regulatory Affairs (Registrations and Post marketing).

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 just to the North of London; 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 and mentor Regulatory Staff. 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.

The Product Portfolio is in Immunology, Oncology, Gastroenterology and Respiratory; however, specific Therapeutic area experience although desirable is not strictly necessary.

Management of overseas Affiliates and other Partners. Liaison with appropriate Regulatory Authorities.

Technically, you will have good working knowledge and experience of CTA's and other Clinical Development activity, Registrations and Post marketing activity: 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.

Candidates from a Pharma or Biologics background in European Pre- and Post-Registrations with over 5 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.

Hertfordshire/Essex location with Hybrid working arrangements.

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.