Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Vollzeitmit HomeofficeSenior
München
Neuer Job?Nejo!
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IMImmatics N.V.
Associate Director Regulatory Affairs – CMC Lead(m/w/x)
München
Vollzeitmit HomeofficeManagement
Nejo KI-Zusammenfassung
Strategic EU CMC regulatory leadership for oncology ATMP programs. 8+ years regulatory affairs CMC experience required. Job bike, job ticket, and relocation allowance.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 8 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- GMP
- CMC
Benefits
Firmenfahrrad
- Job bike
Öffi Tickets
- Job ticket
Gesundheits- & Fitnessangebote
- Health programs
Kinderbetreuung
- Childcare benefits
Sonstige Zulagen
- Relocation allowance
Team Events & Ausflüge
- Company summer and winter events
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Immatics N.V. erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
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IMImmatics N.V.
Associate Director Regulatory Affairs – CMC Lead(m/w/x)
München
Vollzeitmit HomeofficeManagement
Nejo KI-Zusammenfassung
Strategic EU CMC regulatory leadership for oncology ATMP programs. 8+ years regulatory affairs CMC experience required. Job bike, job ticket, and relocation allowance.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 8 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- GMP
- CMC
Benefits
Firmenfahrrad
- Job bike
Öffi Tickets
- Job ticket
Gesundheits- & Fitnessangebote
- Health programs
Kinderbetreuung
- Childcare benefits
Sonstige Zulagen
- Relocation allowance
Team Events & Ausflüge
- Company summer and winter events
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Immatics N.V. erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Immatics N.V.
Branche
Pharmaceuticals
Beschreibung
Immatics N.V. is a global leader in precision targeting of PRAME, driven by a mission to impact the lives of cancer patients.
Noch nicht perfekt?
- Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - ITM Isotope Technologies Munich SE
GPMO Project Manager & CMC Lead(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München - ITM Isotope Technologies Munich SE
Director, Early Development Regulatory Lead(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München - Denk Pharma GmbH & Co. KG
Teamlead International Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen