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.