Associate Director Regulatory Affairs – Clinical Lead*

OVERVIEW

We are currently seeking an Associate Director Regulatory Affairs – Clinical Lead* to strengthen our EU Regulatory team. In this role, you will take ownership of EU regulatory strategy and execution for innovative oncology biopharmaceutical programs, including ATMPs, across early and late-stage development.

You will work in Tübingen, Munich or remote (Germany) in a highly collaborative international environment and act as key regulatory leader within cross-functional teams, ensuring clear, pragmatic, compliant and strategically aligned regulatory positioning.

YOUR MISSION

You will independently lead EU regulatory activities for assigned clinical programs and act as a key driver of regulatory strategy and execution. Your main responsibilities as RA Clinical Lead will include but are not limited to the following tasks:

• Own EU regulatory strategy for assigned programs from First-in-Human through pivotal development and marketing authorization.

• Serve as primary EU regulatory contact for cross-functional teams and provide clear, actionable regulatory guidance while ensuring compliance with regulatory requirements 

• Lead the preparation and coordination of Scientific Advice and other Health Authority interactions, including briefing documents, responses to questions, and meeting follow-up.

• Drive initial clinical trial application and its  lifecycle management, including major Substantial Modifications, with a proactive and risk-based mindset. This includes preparation, review and maintaining documentation of clinical trial applications.

• Identify regulatory risks early and propose pragmatic mitigation strategies.

• Monitor the regulatory landscape, evaluate and translate evolving EU regulatory requirements (including ATMP framework) into strategic implications for development programs.

• Ensure high-quality, coherent regulatory documentation aligned with overall development strategy and compliant with applicable regulatory regulations and guidelines .

• Actively support cross-functional alignment to avoid late-stage regulatory issues and rework.

YOUR PROFILE

• Master’s degree in natural sciences (e.g. Biology, Chemistry or Pharmacy) or Regulatory Affairs

• 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.

• Ability to make sound regulatory decisions in ambiguous situations and to grasp new concepts quickly.

• Pragmatic, risk-based mindset with strong problem-solving skills and a forward-looking, structured approach.

• High degree of personal responsibility, enthusiasm, team spirit, and reliability.

• Experience aligning cross-functional teams and driving resolution of regulatory challenges.

• Proficiency in both written and spoken English and ideally also in German.

WHY US?

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.

NOTICE

*We value diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.