Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Full-timeWith HomeofficeSenior
München
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IMImmatics N.V.
Associate Director Regulatory Affairs – CMC Lead(m/w/x)
München
Full-timeWith Home OfficeManagement
Nejo AI Summary
Strategic EU CMC regulatory leadership for oncology ATMP programs. 8+ years regulatory affairs CMC experience required. Job bike, job ticket, and relocation allowance.
Requirements
- Master or PhD in natural sciences
- 8+ years Regulatory Affairs CMC experience
- Experience assessing regulatory impact of manufacturing changes
- Experience assessing comparability strategies
- Deep understanding of GMP regulatory frameworks
- Deep understanding of CMC regulatory frameworks
- Understanding of EU CMC regulatory frameworks
- Strong experience preparing CMC documents
- Supporting Health Authority interactions
- Proven track record preparing EU Health Authority interactions
- Contributing to EU Health Authority interactions
- Experience with Scientific Advice
- Ability to operate independently
- Make sound regulatory decisions
- Decision making in technically complex environments
- Decision making in evolving environments
- Pragmatic mindset
- Risk-based mindset
- Cross-functional influencing skills
- High degree of personal responsibility
- Enthusiasm
- Team spirit
- Reliability
- Proficiency in written English
- Proficiency in spoken English
- Proficiency in written German
- Proficiency in spoken German
Tasks
- Provide strategic CMC regulatory leadership for oncology biopharmaceutical and ATMP programs
- Lead EU CMC regulatory strategy and execution for assigned programs
- Own EU CMC regulatory strategy for assigned clinical-stage programs (phase I-III)
- Serve as regulatory partner to Quality and Technical Development
- Translate manufacturing, analytical, and process development changes into regulatory impact assessments
- Develop submission strategies for CMC changes
- Drive regulatory strategy for process changes and control strategies
- Drive regulatory strategy for specification setting and comparability assessments
- Identify CMC regulatory risks and propose mitigation approaches
- Ensure compliance with regulatory requirements
- Lead preparation and coordination of CMC/GMP documentation for submissions
- Prepare and review CMC-related information and documents
- Ensure high-quality, strategically coherent CMC regulatory documentation
- Align CMC documentation with development plans and regulations
- Lead preparation of CMC-related Health Authority interactions
- Prepare briefing documents for Health Authority interactions
- Prepare responses to Health Authority questions
- Manage meeting follow-ups with Health Authorities
- Oversee and review external manufacturer documentation for regulatory compliance
- Maintain up-to-date knowledge of CMC regulatory requirements, especially for ATMPs
Work Experience
- 8 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- GMP
- CMC
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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IMImmatics N.V.
Associate Director Regulatory Affairs – CMC Lead(m/w/x)
München
Full-timeWith Home OfficeManagement
Nejo AI Summary
Strategic EU CMC regulatory leadership for oncology ATMP programs. 8+ years regulatory affairs CMC experience required. Job bike, job ticket, and relocation allowance.
Requirements
- Master or PhD in natural sciences
- 8+ years Regulatory Affairs CMC experience
- Experience assessing regulatory impact of manufacturing changes
- Experience assessing comparability strategies
- Deep understanding of GMP regulatory frameworks
- Deep understanding of CMC regulatory frameworks
- Understanding of EU CMC regulatory frameworks
- Strong experience preparing CMC documents
- Supporting Health Authority interactions
- Proven track record preparing EU Health Authority interactions
- Contributing to EU Health Authority interactions
- Experience with Scientific Advice
- Ability to operate independently
- Make sound regulatory decisions
- Decision making in technically complex environments
- Decision making in evolving environments
- Pragmatic mindset
- Risk-based mindset
- Cross-functional influencing skills
- High degree of personal responsibility
- Enthusiasm
- Team spirit
- Reliability
- Proficiency in written English
- Proficiency in spoken English
- Proficiency in written German
- Proficiency in spoken German
Tasks
- Provide strategic CMC regulatory leadership for oncology biopharmaceutical and ATMP programs
- Lead EU CMC regulatory strategy and execution for assigned programs
- Own EU CMC regulatory strategy for assigned clinical-stage programs (phase I-III)
- Serve as regulatory partner to Quality and Technical Development
- Translate manufacturing, analytical, and process development changes into regulatory impact assessments
- Develop submission strategies for CMC changes
- Drive regulatory strategy for process changes and control strategies
- Drive regulatory strategy for specification setting and comparability assessments
- Identify CMC regulatory risks and propose mitigation approaches
- Ensure compliance with regulatory requirements
- Lead preparation and coordination of CMC/GMP documentation for submissions
- Prepare and review CMC-related information and documents
- Ensure high-quality, strategically coherent CMC regulatory documentation
- Align CMC documentation with development plans and regulations
- Lead preparation of CMC-related Health Authority interactions
- Prepare briefing documents for Health Authority interactions
- Prepare responses to Health Authority questions
- Manage meeting follow-ups with Health Authorities
- Oversee and review external manufacturer documentation for regulatory compliance
- Maintain up-to-date knowledge of CMC regulatory requirements, especially for ATMPs
Work Experience
- 8 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- GMP
- CMC
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.
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Full-timeWith HomeofficeSeniorMünchen - Alnylam Pharmaceuticals, Inc.
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Full-timeWith HomeofficeSeniorMünchen - ITM Isotope Technologies Munich SE
GPMO Project Manager & CMC Lead(m/w/x)
Full-timeWith HomeofficeSeniorGarching bei München - ITM Isotope Technologies Munich SE
Director, Early Development Regulatory Lead(m/w/x)
Full-timeWith HomeofficeSeniorGarching bei München - Immatics Biotechnologies GmbH
Director Clinical Sciences(m/w/x)
Full-time/Part-timeWith HomeofficeManagementTübingen, München