Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSenior
München
Neuer Job?Nejo!
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IMImmatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
München
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 8 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
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
Weiterbildungsangebote
- Conferences and trainings
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?
- ITM Isotope Technologies Munich SE
Director, Early Development Regulatory Lead(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München - Immatics Biotechnologies GmbH
Director Clinical Sciences(m/w/x)
Vollzeit/Teilzeitmit HomeofficeManagementTübingen, München - Denk Pharma GmbH & Co. KG
Teamlead International Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - Immatics
(Senior) Manager Clinical Sciences(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenMünchen
IMImmatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
München
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 8 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
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
Weiterbildungsangebote
- Conferences and trainings
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?
- Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - ITM Isotope Technologies Munich SE
Director, Early Development Regulatory Lead(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München - Immatics Biotechnologies GmbH
Director Clinical Sciences(m/w/x)
Vollzeit/Teilzeitmit HomeofficeManagementTübingen, München - Denk Pharma GmbH & Co. KG
Teamlead International Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - Immatics
(Senior) Manager Clinical Sciences(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenMünchen