Senior Manager Regulatory Affairs*

OVERVIEW

We are seeking a Senior Manager Regulatory Affairs* to strengthen our Regulatory Affairs department. In this role, you will lead and further develop our Regulatory Intelligence capabilities, helping translate emerging global regulatory developments into actionable insights for Regulatory Affairs and cross-functional stakeholders. In addition, you will provide targeted support to development programs, including CTA-related clinical and/ or CMC documentation.

You will work in Tübingen, Munich, or remote within Germany in an interdisciplinary environment with colleagues across Germany and the US, contributing to our mission of delivering novel PRAME immunotherapies to patients with cancer.

This position is a fixed-term role of 18 months as it covers a maternity leave.

YOUR MISSION

Your responsibilities will include but are not limited to: 

• Lead the development, optimization and continuous improvement of Regulatory Intelligence tools and processes

• Proactively monitor, assess and interpret emerging global regulatory developments, guidelines, and relevant competitive intelligence

• Translate Regulatory Intelligence information into clear, actionable insights that support our regulatory strategy and cross-functional decision-making

• Drive the review, synthesis and dissemination of regulatory intelligence within Regulatory Affairs and to relevant stakeholders

• Oversee and coordinate the structured documentation, tracking and maintenance of Regulatory Intelligence information within internal systems

• Provide regulatory support for Immatics development programs, including preparation, review and contribution to documentation for CTA applications and subsequent modifications, with a focus on clinical and/ or CMC aspects

• Help ensure that regulatory documentation meets applicable requirements, guidelines, and quality standards

YOUR PROFILE

• Master’s degree in Life Sciences, Healthcare, or a related discipline; a Master’s degree in Regulatory Affairs is a plus

• 5+ years of experience in Regulatory Affairs within the biopharmaceutical industry; experience in Regulatory Intelligence and/ or development Regulatory Affairs

• Experience with biologics and/ or ATMPs is strongly preferred

• Strong analytical mindset with the ability to interpret complex regulatory environments and translate insights into strategy

• Proven ability to work independently while effectively collaborating in cross-functional and international teams

• Highly organized, proactive, and adaptable, with a forward-thinking and solution-oriented approach

• Excellent stakeholder engagement and communication skills in English (C1 or higher); German is advantageous

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. 

ABOUT IMMATICS

Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics. Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates, you can also follow us on LinkedIn and Instagram.