Walker Cole is supporting a growing pharmaceutical organisation in the search for a Senior Regulatory Manager to join its regulatory team permanently.
This is a key role responsible for leading regulatory strategy, Centralised Procedure (CP) submissions, lifecycle management, and due diligence activities across a diverse portfolio of pharmaceutical products in the UK & EU markets.
The ideal candidate will combine strong experience in innovative / specialty products with solid expertise in MAH lifecycle management and regulatory operations.
Key Responsibilities:
• Lead and implement regulatory strategy across UK, EU and international markets
• Manage Centralised Procedure (EMA) submissions, variations, renewals and lifecycle activities
• Lead regulatory due diligence for in-licensing and acquisition opportunities
• Provide regulatory input into product development, launches and portfolio expansion
• Act as a key contact for MHRA, EMA and other regulatory authorities
• Ensure ongoing compliance of Marketing Authorisations (MAH responsibilities)
• Oversee labelling, packaging artwork and regulatory documentation
• Coordinate responses to authority questions, deficiency letters and inspections
• Support cross-functional teams (Quality, Supply Chain, Commercial, BD, Medical)
• Contribute to regulatory governance, SOPs, change control and compliance processes
About You:
• 5–10 years’ experience in pharmaceutical Regulatory Affairs
• Strong experience in MAH environment with lifecycle management (UK & EU MAs)
• Proven experience in Centralised Procedure (CP) / EMA submissions
• Experience in due diligence and in-licensing / acquisition assessments
• Background in innovative and/or specialty pharmaceutical products (advantageous)
• Strong knowledge of MHRA, EMA, ICH guidelines and EU/UK legislation
• Experience managing cross-functional regulatory projects and product launches
• Strong stakeholder management, communication and decision-making skills
• Proactive, detail-oriented and solution-driven mindset
Regulatory Affairs / Senior Regulatory Manager / MAH / EMA / MHRA / Centralised Procedure / CP / Due Diligence / Lifecycle Management / Variations / Renewals / Innovative Pharma / UK & EU Regulatory Affairs / Permanent Role/110465/110333
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