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