Job Description
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 ResponsibilitiesLead 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...
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