Regulatory Affairs Manager Uk and Ire

Your newpany
This leading global biopharmaceuticalpany is looking for an experienced Regulatory Affairs Manager to join their UK Affiliate Regulatory team on a maternity cover basis. This is a high-impact role working on established products approved via the EMA Centralised Procedure, with strong exposure to post-approval lifecycle activities.

Your new role
Reporting to the Head of UK Regulatory, you will take ownership of one or more products of mediumplexity and strategic impact, working closely with UK, Ireland, and EU regulatory stakeholders.Key Responsibilities

Lead post-MAA lifecycle management activities for assigned products

Manageplex Type II variations and other regulatory procedures

Support and maintain Paediatric Investigation Plans (PIPs)

Contribute to clinical trial regulatory activities as required

Plan and execute local regulatory submissions in line with EMA, MHRA, and corporate standards.

Prov...