Repairon is pioneering a cell-based therapy (Engineered Heart Muscle) for patients with advanced heart failure. As we move through clinical trials and early access programs, we're looking for an experienced professional to drive our clinical operations and regulatory strategy.
Your mission :
1. Lead clinical trial operations from planning to execution
2. Be the primary contact for regulatory authorities (PEI, EMA)
3. Manage submissions, safety documentation, and early access processes
4. Help shape a sustainable regulatory path for our ATMP
5. Collaborate closely across medical, regulatory & commercial teams
6. Build and lead our Regulatory Affairs function
Your profile :
* Background in Medicine or Life Sciences
* Strong clinical trial experience (GCP, AMG), ideally incl. ATMPs
* Regulatory know-how (submissions, approvals, §4b AMG)
* Strategic mindset & hands-on execution skills
What we offer :
* A high-impact role in a fast-growing biotech
* Agile, interdisciplinary team culture
* Flexibility, autonomy & close collaboration with leadership
* The chance to build a therapy with real-world impact
Interested? Let’s talk!
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