Associate Director Regulatory Affairs

Associate Director Regulatory Affairs

Remote from the U.K.

A rapidly growing, clinical-stage biotech is expanding its European Regulatory team and is looking to appoint an Associate Director, Regulatory Affairs to support global Oncology development programs, with a focus on EU strategy and submissions.

The Role

• Support and contribute to regulatory strategy across clinical-stage programs
• Lead preparation and submission of CTA/MAA and lifecycle activities to EMA and other health authorities.
• Partner with cross-functional teams to ensure regulatory requirements are integrated into development plans.
• Support interactions with health authorities (briefing packages, responses, submissions).
• Ensure compliance with EU regulations, ICH guidelines, and GxP standards.
• Contribute to regulatory documentation and support submission delivery timelines.

Requirements

• 6–10 years’ experience in Regulatory Affairs (biotech/pharma)
• Experience leading clinical Regulatory strategy
• Strong experience with EU regulatory submissions (CTA/MAA)
• Oncology experience is highly desired.
• Experience with expedited regulatory pathways/designations, e.g., ODD, BT, AA, etc.
• Strong communication skills and ability to work cross-functionally
• Degree in Life Sciences (advanced degree a plus)

Why Join?

• Key role in a growing biotech with a strong pipeline
• Opportunity to work across EU and global programs
• Collaborative, fast-paced environment with real impact on development programs
• Competitive package + bonus + equity

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