(Senior) Manager Regulatory Affairs - Submission Lead

(Senior) Manager Regulatory Affairs - Submission Lead* page is loaded

(Senior) Manager Regulatory Affairs - Submission Lead*

Apply

locations Munich Tuebingen (Germany)Remote Work (Germany)

time type Full time

posted on Vor 3 Tagen ausgeschrieben

job requisition id JR100668

OVERVIEW

We are currently seeking a *full-time (40 hrs)**(Senior) Manager Regulatory Affairs – Submission Lead to strengthen our Regulatory Affairs department. You will work in Tübingen, Munich or remote (Germany) in an interdisciplinary environment with colleagues from Germany and the US and will contribute to our mission of delivering novel PRAME immunotherapies to patients with cancer.

This position is a fixed-term role of 24 months as it covers a maternity leave.

YOUR MISSION

Your main responsibilities will include but are not limited to the following tasks:

• Serve as the EU Submission Lead for assigned clinical trials and act as primary contact for submission planning and execution.
• Lead the preparation and submission of initial applications and amendments via CTIS and oversee end-of-trial submissions.
• Coordinate all regulatory submission activities in collaboration with the Regulatory Affairs Project Lead, including coordination of external vendors and partners.
• Ensure compliance with regulatory requirements, provide regulatory oversight for site-related documentation, and ensure timely delivery of complete and accurate Part II application packages.
• Drive submission readiness, including compilation, document status tracking, timeline management, and formal-validity checks for complete application packages.
• Oversee regulatory filing readiness and handoff to eTMF filing processes.
• Ensure clear and timely regulatory communication across cross-functional teams.
• Coordinate the preparation and submission of timely Request for Information responses in collaboration with the Regulatory Affairs Project Lead.
• Contribute to regulatory intelligence and maintain current knowledge of EU and global regulatory requirements.

YOUR PROFILE

You hold a Master’s degree in Life Sciences and have gained 2+ years of experience in the submission of clinical trials in the EU via CTIS. Knowledge of submissions in non-EU countries is an advantage. Your experience enables you to successfully contribute to cross-functional work in multidisciplinary teams. You are interested in contributing to innovative clinical research, and you take working in teams, paying attention to detail, and consistently meeting timelines for granted.

We expect a high degree of independent working, analytical reasoning and excellent communication skills in English (at least C1-Level); German is an advantage. You embrace rapidly changing requirements with an open mind, think outside the box and show a high degree of flexibility in an environment which is marked by a constant striving for excellence. Approaching tasks in a structured, reliable, and forward-thinking manner, you demonstrate a high level of individual responsibility, enthusiasm, and proactiveness.

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.