Associate Director Regulatory Affairs - CMC Lead | Pharmacist (m/w/d)
Immatics Biotechnologies GmbH
Job Summary
This Associate Director role is a strategic leadership position focused on Chemistry, Manufacturing, and Controls (CMC) for innovative oncology biopharmaceutical and Advanced Therapy Medicinal Product (ATMP) programs. You will be responsible for leading EU CMC regulatory strategies from Phase I through Phase III clinical development. Day-to-day, you will act as the primary regulatory interface for Quality and Technical Development teams, translating complex manufacturing and analytical changes into clear regulatory impact assessments and submission strategies. You will lead the preparation of CMC documentation for clinical trial applications and manage interactions with Health Authorities, including Scientific Advice meetings. This position is particularly attractive due to its focus on cutting-edge ATMP programs and the flexibility of working from Tübingen, Munich, or remotely within Germany. The role offers a high degree of independence and the opportunity to work within a mission-driven culture dedicated to precision cancer targeting.
Required Skills
Education
Master's degree or PhD in natural sciences (e.g., Biology, Chemistry, or Pharmacy).
Experience
- 8+ years of Regulatory Affairs CMC experience specifically for Biologics and/or ATMPs
- Professional experience assessing regulatory impact of manufacturing changes and comparability strategies
- Proven track record in preparing and contributing to EU Health Authority interactions such as Scientific Advice
- Demonstrated experience preparing CMC documentation for clinical trial applications and substantial modifications
- Experience in cross-functional leadership and influencing within technically complex environments
Languages
Additional
- The role allows for remote work within Germany or office-based work in Tübingen or Munich. Candidates must have a deep understanding of EU CMC regulatory frameworks.