Walker Cole International is supporting a pharmaceutical company in the search for a Regulatory CMC Officer to join their growing Regulatory team in the UK.
This position will support regulatory lifecycle activities across a portfolio of specialty pharmaceutical products distributed across UK and European markets.
The role offers strong exposure to CMC regulatory activities, post-approval submissions, and international lifecycle management within a fast-paced and collaborative environment.
Key responsibilities:
• Support regulatory lifecycle management activities across UK and European markets
• Prepare and submit CMC regulatory documentation, including variations and post-approval changes
• Coordinate regulatory submissions in line with MHRA and European regulatory requirements
• Maintain regulatory compliance for existing marketed products across multiple territories
• Work cross-functionally with Quality, Supply Chain, Medical Affairs, and commercial teams
• Support artwork and labelling updates where required
• Monitor regulatory changes and support implementation activities across the portfolio
About you:
• 2–3 years of Regulatory Affairs experience within the pharmaceutical industry
• Strong exposure to CMC regulatory activities and lifecycle management
• Experience preparing and managing regulatory submissions and variations
• Understanding of UK and/or EU pharmaceutical regulatory frameworks
• Strong organisational skills with the ability to manage multiple projects simultaneously
• Comfortable working within a collaborative and evolving business environment
Regulatory Affairs / CMC / Variations / Lifecycle Management / MHRA / EU Regulations / Pharmaceutical / Specialty Pharma / Post-Approval Submissions / Regulatory Officer