Head of Clinical & Regulatory Affairs (m / f / d)

Repairon GmbH; Göttingen; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Join a pioneering biotech firm making strides in cell-based therapy for heart failure. In this impactful role, you will lead clinical trial operations and regulatory strategies, ensuring compliance and collaboration across teams. With a focus on building a sustainable regulatory path for innovative therapies, you will work in an agile and interdisciplinary environment. This opportunity offers flexibility, autonomy, and the chance to contribute to a therapy that truly makes a difference in patients' lives. If you are driven by purpose and ready to take on a high-impact role, we invite you to connect with us.

Leistungen

Flexible Work Environment

Autonomy in Role

Interdisciplinary Team Culture

High-Impact Role

Qualifikationen

• Experience in leading clinical trials from planning to execution.
• Strong regulatory knowledge for submissions and approvals.

Aufgaben

• Lead clinical trial operations and manage regulatory submissions.
• Collaborate across medical, regulatory, and commercial teams.

Kenntnisse

Clinical Trial Management

Regulatory Affairs

Good Clinical Practice (GCP)

Advanced Therapy Medicinal Products (ATMPs)

Strategic Planning

Ausbildung

Degree in Medicine

Degree in Life Sciences

Jobbeschreibung

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!