Immatics
Life Sciences
(Senior)ManagerRegulatoryAffairsSubmissionLead
“(Senior) Manager Regulatory Affairs - Submission Lead at Immatics. Skills: Regulatory Affairs, Submission Lead, CTIS. Serve as EU Submission Lead for clinical trials. Act as primary contact for submission planning”
What You'll Achieve.
delivering novel PRAME immunotherapies to patients with cancer; timely delivery of complete and accurate Part II application packages; timely Request for Information responses
Industry & Context.
analytical reasoning; think outside the box
fixed-term role of 24 months
What They're Looking For.
Must Have
Master’s degree in Life Sciences, 2+ years of experience in the submission of clinical trials in the EU via CTIS
Nice to Have
Knowledge of submissions in non-EU countries
What You'll Do.
Serve as EU Submission Lead for clinical trials
Act as primary contact for submission planning
Lead preparation and submission of initial applications
Oversee end-of-trial submissions
Coordinate regulatory submission activities
Ensure compliance with regulatory requirements
Provide regulatory oversight for site-related documentation
Ensure timely delivery of Part II application packages
Drive submission readiness
Compile and track document status
Perform formal-validity checks
Oversee regulatory filing readiness
Coordinate Request for Information responses
Contribute to regulatory intelligence
Maintain current knowledge of regulatory requirements
How You'll Work.
Team & Collaboration
Work in an interdisciplinary environment; Collaborate with colleagues from Germany and the US; Contribute to cross-functional work in multidisciplinary teams; Ensure clear and timely regulatory communication across cross-functional teams
Communication Scope
excellent communication skills in English (at least C1-Level)
Process & Methodology
timeline management
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