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Regulatory affairs manager uk and ire

Uxbridge
Hays Life Sciences
Regulatory affairs manager
Posted: 10h ago
Offer description

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...

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