Regulatory CMC Officer

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