EU Regulatory Affairs, Sr Manager (Contractor)

1 Year (FREELANCE) Contract Opportunity : EU Regulatory Affairs - Senior Manager (Biotech)

A leading biotechnology company is seeking a highly experienced EU Regulatory Affairs Senior Manager to support development-stage projects and initial Marketing Authorisation Applications (MAAs) across Europe.

Key Responsibilities :

• Lead and support EU Clinical Trial Authorisation (CTA) submissions and amendments via CTIS.
• Manage Paediatric Investigational Plans (PIPs) and full waivers.
• Prepare for and participate in EMA and national Health Authority meetings, including Scientific Advice.
• Collaborate with cross-functional teams across Europe and Asia.
• Monitor and interpret evolving EU regulatory guidance relevant to clinical development.

Candidate Profile :

If you are interested in contributing to impactful regulatory work in a dynamic biotech environment, please get in touch or submit your CV for more information.