OVERVIEW

We are currently seeking an Associate Director Regulatory Affairs - CMC Lead* to strengthen our Regulatory team. In this role, you will provide strategic CMC regulatory leadership for innovative oncology biopharmaceutical and ATMP programs across clinical development phases.


You will work in Tübingen, Munich or remote (Germany) and act as the key regulatory interface for CMC topics, working closely with Quality, Global Drug Supply and external manufacturing partners to ensure robust, pragmatic, and compliant CMC strategies.
You will independently lead EU CMC regulatory strategy and execution for assigned programs across early and late-stage clinical development. Your main responsibilities will include but are not limited to the following tasks:



Own EU CMC regulatory strategy for assigned clinical-stage programs (phase I-III).
Serve as regulatory partner to Quality and Technical Development, ensuring alignment while maintaining a risk-based regulatory perspective.
Translate manufacturing, analytical, and process development changes into clear regulatory impact assessments and submission strategies.
Drive regulatory strategy for process changes, control strategies, specification setting, and comparability assessments.
Proactively identify CMC regulatory risks (e.g., comparability, specification changes, site transfers) and propose pragmatic mitigation approaches while ensuring compliance with regulatory requirements.
Lead preparation and coordination of CMC/ GMP documentation for submission of initial clinical trial applications as well as Substantial Modifications. This includes preparation, review and maintenance of CMC-related information and documents.
Ensure high-quality, strategically coherent CMC regulatory documentation aligned with overall development plans and compliant with applicable regulatory regulations and guidelines.
Lead preparation of CMC-related Health Authority interactions, including briefing documents, responses to questions, and meeting follow-ups.
Oversight and review of external manufacturer documentation for regulatory compliance.
Maintain up-to-date knowledge of CMC regulatory requirements and expectations, particularly for ATMPs.

Master or PhD in natural sciences (e.g., Biology, Chemistry or Pharmacy).
8+ years of Regulatory Affairs CMC experience for Biologics and/ or ATMPs.
Demonstrated experience assessing regulatory impact of manufacturing changes and comparability strategies.
Deep understanding of GMP and CMC regulatory frameworks, particularly for EU.
Strong experience preparing CMC-related information/ documents for clinical trial applications and supporting Health Authority interactions.
Proven track record preparing and contributing to EU Health Authority interactions (e.g., Scientific Advice).
Ability to operate independently and make sound regulatory decisions in technically complex and evolving environments.
Pragmatic, risk-based mindset with strong cross-functional influencing skills.
High degree of personal responsibility, enthusiasm, team spirit, and reliability.
Proficiency in both written and spoken English and ideally also in German.
We are the global leader in precision targeting of PRAME. Driven by our mission to make an impact on the lives of patients with cancer, we are a committed and inspired team and cherish the collegial, highly motivated, and family- friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking, and initiative. We believe in supporting our employees’ professional and social skills: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits - e.g., job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events.