Associate Director, Regulatory Affairs

About the role

Leads UK regulatory strategy for development programmes and oversees commercial products in the UK and Ireland, securing and keeping marketing authorisations aligned with business goals.

What you will do

• Direct the UK regulatory team across development, registration, approval and lifecycle stages for assigned compounds
• Shape UK marketing authorisation strategy with internal partners and embed it in development plans
• Prepare and manage UK submission dossiers, drawing on EU dossier content for labelling updates in Ireland
• Review promotional materials for the UK and Ireland and represent regulatory on the UK leadership team
• Coach junior regulatory staff and represent the company at UK industry association meetings and congresses

What they look for

• At least eight years in the biotech or pharma industry, including eight or more in a broad regulatory role
• Hands-on experience with MHRA regulatory procedures
• Solid grasp of drug development, the pharma sector and UK regulatory policy trends
• Track record of delivering goals within cross-functional teams and partnerships with high professionalism
• Bachelor's degree, with an advanced degree preferred
• Extensive familiarity with Microsoft Office, Veeva regulatory publishing and PowerPoint authoring

Nice to have

• Recent work with oncology products, marketing authorisation applications, orphan drug designations and paediatric investigation plans