Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Full-timeWith HomeofficeSenior
München
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IMImmatics N.V.
Manager Regulatory Affairs – Submission Lead(m/w/x)
München
Full-timeWith Home OfficeExperienced
Nejo AI Summary
EU clinical trial submission lead via CTIS, coordinating initial applications and end-of-trial filings. 2+ years of CTIS submission experience required. Job bike, job ticket, and relocation allowance.
Requirements
- Master’s degree in Life Sciences
- 2+ years of experience in EU clinical trial submissions via CTIS
- Knowledge of non-EU country submissions (advantageous)
- Experience in cross-functional team contributions
- Interest in innovative clinical research
- Teamwork skills
- Attention to detail
- Consistent meeting of timelines
- High degree of independent working
- Analytical reasoning skills
- Excellent English communication skills (C1-Level)
- German language skills (advantageous)
- Embracing rapidly changing requirements
- Thinking outside the box
- High degree of flexibility
- Structured, reliable, and forward-thinking approach
- High level of individual responsibility
- Enthusiasm and proactiveness
Tasks
- Serve as EU Submission Lead for clinical trials
- Act as primary contact for submission planning and execution
- Lead preparation and submission of initial applications and amendments
- Oversee end-of-trial submissions via CTIS
- Coordinate regulatory submission activities with project lead
- Collaborate with external vendors and partners
- Ensure compliance with regulatory requirements
- Provide regulatory oversight for site-related documentation
- Ensure timely delivery of complete and accurate Part II application packages
- Drive submission readiness and compilation
- Track document status and manage timelines
- Conduct formal-validity checks for application packages
- Oversee regulatory filing readiness
- Hand off to eTMF filing processes
- Ensure clear and timely regulatory communication across teams
- Prepare and submit timely Request for Information responses
- Contribute to regulatory intelligence
- Maintain current knowledge of EU and global regulatory requirements
Work Experience
- 2 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- CTIS
Benefits
Company Bike
- Job bike
Public Transport Subsidies
- Job ticket
Healthcare & Fitness
- Health Programs
Childcare
- Childcare benefits
Additional Allowances
- Relocation allowance
Team Events
- Company summer and winter events
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Immatics N.V. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Associate Director, Regulatory Affairs(m/w/x)
Full-timeWith HomeofficeSeniorMünchen - Immatics
(Senior) Manager Clinical Sciences(m/w/x)
Full-timeWith HomeofficeExperiencedMünchen
IMImmatics N.V.
Manager Regulatory Affairs – Submission Lead(m/w/x)
München
Full-timeWith Home OfficeExperienced
Nejo AI Summary
EU clinical trial submission lead via CTIS, coordinating initial applications and end-of-trial filings. 2+ years of CTIS submission experience required. Job bike, job ticket, and relocation allowance.
Requirements
- Master’s degree in Life Sciences
- 2+ years of experience in EU clinical trial submissions via CTIS
- Knowledge of non-EU country submissions (advantageous)
- Experience in cross-functional team contributions
- Interest in innovative clinical research
- Teamwork skills
- Attention to detail
- Consistent meeting of timelines
- High degree of independent working
- Analytical reasoning skills
- Excellent English communication skills (C1-Level)
- German language skills (advantageous)
- Embracing rapidly changing requirements
- Thinking outside the box
- High degree of flexibility
- Structured, reliable, and forward-thinking approach
- High level of individual responsibility
- Enthusiasm and proactiveness
Tasks
- Serve as EU Submission Lead for clinical trials
- Act as primary contact for submission planning and execution
- Lead preparation and submission of initial applications and amendments
- Oversee end-of-trial submissions via CTIS
- Coordinate regulatory submission activities with project lead
- Collaborate with external vendors and partners
- Ensure compliance with regulatory requirements
- Provide regulatory oversight for site-related documentation
- Ensure timely delivery of complete and accurate Part II application packages
- Drive submission readiness and compilation
- Track document status and manage timelines
- Conduct formal-validity checks for application packages
- Oversee regulatory filing readiness
- Hand off to eTMF filing processes
- Ensure clear and timely regulatory communication across teams
- Prepare and submit timely Request for Information responses
- Contribute to regulatory intelligence
- Maintain current knowledge of EU and global regulatory requirements
Work Experience
- 2 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- CTIS
Benefits
Company Bike
- Job bike
Public Transport Subsidies
- Job ticket
Healthcare & Fitness
- Health Programs
Childcare
- Childcare benefits
Additional Allowances
- Relocation allowance
Team Events
- Company summer and winter events
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Immatics N.V. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Immatics N.V.
Industry
Pharmaceuticals
Description
Immatics N.V. is a global leader in precision targeting of PRAME, driven by a mission to impact the lives of cancer patients.
Not a perfect match?
- Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Full-timeWith HomeofficeSeniorMünchen - Immatics N.V.
Associate Director Regulatory Affairs – CMC Lead(m/w/x)
Full-timeWith HomeofficeManagementMünchen - ITM Isotope Technologies Munich SE
Director, Early Development Regulatory Lead(m/w/x)
Full-timeWith HomeofficeSeniorGarching bei München - Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Full-timeWith HomeofficeSeniorMünchen - Immatics
(Senior) Manager Clinical Sciences(m/w/x)
Full-timeWith HomeofficeExperiencedMünchen