Senior Associate Regulatory CMC - Biologics, top Biopharma

Excellent opportunity for a Senior Associate Regulatory CMC, or an experienced Regulatory CMC Associate, with a solid background in Regulatory CMC and ideally Biologics (not essential)

Working knowledge of Biologic products is ideal although Pharma Product experience can be considered.

This leading Biopharma Company seeks a Senior Regulatory Officer for their team based in Central London with Hybrid Working offered; ideally, you will be seasoned in the following processes: CTA's, IMPD's (CMC sections); CTD/Dossiers for MAA's (Modules 2.3 and 3); European Procedures: mainly Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals.

It is generally accepted that this company is a superb organisation to learn and develop new Regulatory CMC skills.

Liaise closely with Regulatory CMC Managers, Business Development, other Regulatory Affairs, Pharmacovigilance, Product Launch, Supply Chain and Quality colleagues to ensure alignment in all initiatives.

Contribute to Regulatory Strategies (including advising of the Regulatory requirements) for new Marketing Authorisation Applications / Post-approval Submissions.

Be actively involved in due diligence activities including evaluation of Regulatory Strategy and launch timelines, evaluation of risk.

Candidates from a Biopharma or Pharma background in European Regulatory CMC and Life-cycle management with over 3+ years' experience, and good all-round Regulatory CMC 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.

£55,000 basic, 12% bonus, LTIs'/RSU's and other leading benefits are offered. Central London location with Hybrid Working.

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.