Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Full-timeWith HomeofficeSenior
München
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IMImmatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading EU regulatory strategy for clinical programs targeting PRAME in cancer therapy. 8+ years Regulatory Affairs experience in biopharmaceuticals/ATMPs required. Relocation allowance, job bike, and childcare benefits.
Requirements
- Master's degree in natural sciences (Biology, Chemistry, Pharmacy) or Regulatory Affairs
- 8+ years Regulatory Affairs experience in biopharmaceuticals/ATMPs
- Experience leading EU regulatory strategy for clinical programs
- Track record preparing/contributing to EU Health Authority interactions
- Strong experience with CTA preparation and lifecycle management
- Sound regulatory decision-making and quick concept grasping
- Pragmatic, risk-based mindset, strong problem-solving, structured approach
- High personal responsibility, enthusiasm, team spirit, reliability
- Experience aligning cross-functional teams and resolving regulatory challenges
- Proficiency in written/spoken English, ideally German
Tasks
- Lead EU regulatory strategy for programs through marketing authorization
- Act as primary EU regulatory contact
- Provide clear, actionable regulatory guidance
- Ensure compliance with regulatory requirements
- Lead Health Authority interactions preparation and coordination
- Prepare briefing documents for interactions
- Draft responses to Health Authority questions
- Manage follow-up for Health Authority meetings
- Drive initial clinical trial applications
- Manage clinical trial application lifecycle
- Prepare, review, and maintain clinical trial documentation
- Identify regulatory risks and propose mitigation strategies
- Monitor the EU regulatory landscape
- Evaluate evolving EU regulatory requirements
- Translate requirements into strategic implications for programs
- Ensure high-quality, compliant regulatory documentation
- Align documentation with development strategy
- Support cross-functional alignment to prevent issues
Work Experience
- 8 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
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
Learning & Development
- Conferences and trainings
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.
Not a perfect match?
- ITM Isotope Technologies Munich SE
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Teamlead International Regulatory Affairs(m/w/x)
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IMImmatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading EU regulatory strategy for clinical programs targeting PRAME in cancer therapy. 8+ years Regulatory Affairs experience in biopharmaceuticals/ATMPs required. Relocation allowance, job bike, and childcare benefits.
Requirements
- Master's degree in natural sciences (Biology, Chemistry, Pharmacy) or Regulatory Affairs
- 8+ years Regulatory Affairs experience in biopharmaceuticals/ATMPs
- Experience leading EU regulatory strategy for clinical programs
- Track record preparing/contributing to EU Health Authority interactions
- Strong experience with CTA preparation and lifecycle management
- Sound regulatory decision-making and quick concept grasping
- Pragmatic, risk-based mindset, strong problem-solving, structured approach
- High personal responsibility, enthusiasm, team spirit, reliability
- Experience aligning cross-functional teams and resolving regulatory challenges
- Proficiency in written/spoken English, ideally German
Tasks
- Lead EU regulatory strategy for programs through marketing authorization
- Act as primary EU regulatory contact
- Provide clear, actionable regulatory guidance
- Ensure compliance with regulatory requirements
- Lead Health Authority interactions preparation and coordination
- Prepare briefing documents for interactions
- Draft responses to Health Authority questions
- Manage follow-up for Health Authority meetings
- Drive initial clinical trial applications
- Manage clinical trial application lifecycle
- Prepare, review, and maintain clinical trial documentation
- Identify regulatory risks and propose mitigation strategies
- Monitor the EU regulatory landscape
- Evaluate evolving EU regulatory requirements
- Translate requirements into strategic implications for programs
- Ensure high-quality, compliant regulatory documentation
- Align documentation with development strategy
- Support cross-functional alignment to prevent issues
Work Experience
- 8 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
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
Learning & Development
- Conferences and trainings
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?
- Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Full-timeWith HomeofficeSeniorMünchen - 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 - Denk Pharma GmbH & Co. KG
Teamlead International Regulatory Affairs(m/w/x)
Full-timeWith HomeofficeSeniorMünchen - Immatics
(Senior) Manager Clinical Sciences(m/w/x)
Full-timeWith HomeofficeExperiencedMünchen