Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Vollzeitmit HomeofficeSenior
München
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
IMImmatics N.V.
Manager Regulatory Affairs – Submission Lead(m/w/x)
München
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 2 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- CTIS
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?
- Immatics N.V.
Associate Director Regulatory Affairs – CMC Lead(m/w/x)
Vollzeitmit HomeofficeManagementMünchen - ITM Isotope Technologies Munich SE
Director, Early Development Regulatory Lead(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München - Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - ITM Isotope Technologies Munich SE
Medical Affairs Manager - Publications(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGarching bei München
IMImmatics N.V.
Manager Regulatory Affairs – Submission Lead(m/w/x)
München
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 2 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- CTIS
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 - Immatics N.V.
Associate Director Regulatory Affairs – CMC Lead(m/w/x)
Vollzeitmit HomeofficeManagementMünchen - ITM Isotope Technologies Munich SE
Director, Early Development Regulatory Lead(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München - Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - ITM Isotope Technologies Munich SE
Medical Affairs Manager - Publications(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGarching bei München