Regulatory Affairs Manager Uk and Ire Uxbridge - Job

Regulatory Affairs Manager Uk and Ire

Your new company
This leading global biopharmaceutical company 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 medium complexity and strategic impact, working closely with UK, Ireland, and EU regulatory stakeholders.Key Responsibilities

Lead post-MAA lifecycle management activities for assigned products
Manage complex 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.
Provide local regulatory input into global regulatory strategies
Ensure product compliance, including IMR, PMCs, and agency commitments
Develop and maintain local product labels in line with legislation and internal standards
Review promotional and non-promotional materials (where in scope)
Act as the primary point of contact with regulatory authorities
Support alignment between local regulatory requirements and global processes

What you'll need to succeed

Proven experience in UK/EU Regulatory Affairs within pharma or biotech
Strong background in post-approval regulatory lifecycle management
Demonstrated experience handling Type II variations
Hands-on experience with PIPs
Exposure to clinical trial regulatory submissions
Familiarity with Veeva Regulatory systems (preferred)
Experience working with centrally approved products via the EMA

What you'll get in return
Remote working

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
For more information on this or any other Regulatory Affairs contract jobs, please apply to this advert.

Apply Now

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