Senior Manager Regulatory Affairs

1w1 week ago

Immatics

Munich, DE · Temporary · €90,000 – €130,000

About this role

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

This is a fixed-term role of 18 months covering a maternity leave. You will work in Tübingen, Munich, or remote within Germany in an interdisciplinary environment with colleagues across Germany and the US. Contribute to delivering novel PRAME immunotherapies to patients with cancer.

Day-to-day involves proactively monitoring and assessing global regulatory developments, guidelines, and competitive intelligence. Translate this into clear insights supporting regulatory strategy and cross-functional decision-making. Oversee documentation and tracking of Regulatory Intelligence within internal systems.

Join a committed and inspired team in a collegial, highly motivated, family-friendly atmosphere. Benefit from high originality, independent thinking, and initiative. Access conferences, trainings, job bike, job ticket, Health Programs, childcare benefits, relocation allowance, and company events.

Requirements

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

Responsibilities

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 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 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