Associate Director Regulatory Affairs - Clinical Lead | Pharmacist (m/w/d)
Immatics Biotechnologies GmbH
Job Summary
Join a leading biopharmaceutical company as an Associate Director of Regulatory Affairs - Clinical Lead, focusing on innovative oncology biopharmaceutical programs, including ATMPs. You will own the EU regulatory strategy and execution from early-stage development through marketing authorization. This role involves acting as a key regulatory leader within cross-functional teams, guiding strategy, preparing for Health Authority interactions, and managing clinical trial applications. The position offers a unique opportunity to work in a highly collaborative international environment, driving regulatory success for critical patient treatments. Ideal candidates possess a strong background in EU regulatory affairs for clinical-stage programs, a pragmatic problem-solving approach, and excellent communication skills.
Required Skills
Education
Master’s degree in natural sciences (e.g. Biology, Chemistry or Pharmacy) or Regulatory Affairs
Experience
- 8+ years of Regulatory Affairs experience in biopharmaceuticals and/or ATMPs
- Demonstrated experience leading EU regulatory strategy for clinical-stage programs
- Proven track record preparing and contributing to EU Health Authority interactions (e.g., Scientific Advice)
- Strong experience with CTA preparation and lifecycle management in Europe
- Experience aligning cross-functional teams and driving resolution of regulatory challenges
Languages
Additional
- Must be authorized to work in Germany (Tübingen, Munich, or remote in Germany).