Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Vollzeitmit HomeofficeSenior
München
Neuer Job?Nejo!
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ITITM Isotope Technologies Munich SE
Director, Early Development Regulatory Lead(m/w/x)
Garching bei München
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading projects for radiopharmaceuticals in cancer treatment, focusing on IND/CTA submissions and FDA/EMA interactions. 7-10 years experience with pharma/biotech submissions and health authority interactions, including direct FDA/EMA, required. Flexible hybrid work options.
Anforderungen
- Degree in pharmacy, chemistry, biochemistry, biotechnology, or related field
- 7–10 years of regulatory experience in pharma, biotech, or authorities
- Knowledge of pharmaceutical development and IND/CTA regulations
- Ability to integrate oncology drug regulations into development plans
- Experience in direct interactions with FDA and EMA
- Excellent English skills and optional German fluency
Aufgaben
- Expertly lead early-stage radiopharmaceutical development projects
- Focus on upcoming IND and CTA submissions
- Report directly to the Head of Clinical Regulatory Affairs
- Act as primary contact for the FDA and EMA
- Manage regulatory interactions and operational submissions
- Collaborate closely with subject matter experts and project teams
- Lead scientific Health Authority meetings and protocol assistance
- Oversee timely filing of original and amendment INDs and CTAs
- Develop global regulatory strategies for product candidates
- Align regulatory plans with clinical development objectives
- Identify risks and implement mitigation strategies
- Coordinate high-quality responses to Health Authority requests
- Optimize submission strategies using appropriate regulatory pathways
- Review and approve clinical and non-clinical documents
- Author product-specific briefing books and regulatory reports
- Provide proactive guidance to clinical trial teams
- Stay current with evolving global regulatory guidelines
- Support business development and departmental initiatives
Berufserfahrung
- 7 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- IND regulations
- CTA regulations
- FDA
- EMA
Benefits
Flexibles Arbeiten
- Hybrid working model
- Flexible working hours
- Home office options
Abwechslungsreiche Aufgaben
- Exciting challenges
Lockere Unternehmenskultur
- Creative freedom
- Open working atmosphere
- International corporate culture
- Short communication channels
Weiterbildungsangebote
- Comprehensive onboarding programme
- Individually tailored training programme
- German and English courses
Boni & Prämien
- Attractive special payments
Attraktive Vergütung
- Employee participation programme
Firmenfahrrad
- Job bike
Öffi Tickets
- Subsidised job ticket
Betriebliche Altersvorsorge
- Company pension scheme contribution
Gesundheits- & Fitnessangebote
- Health promotion programmes
- EGYM Wellpass
- Fitness studio subsidy
Team Events & Ausflüge
- Sponsorship of sporting events
Mentoring & Coaching
- Lifestyle coaching sessions
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ITM Isotope Technologies Munich SE 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?
- Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - ITM Isotope Technologies Munich SE
Medical Affairs Manager(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGarching bei München - ITM Isotope Technologies Munich SE
Head of Early Pipeline Strategy(m/w/x)
Vollzeitmit HomeofficeManagementMünchen - Immatics Biotechnologies GmbH
Director Clinical Sciences(m/w/x)
Vollzeit/Teilzeitmit HomeofficeManagementTübingen, München
ITITM Isotope Technologies Munich SE
Director, Early Development Regulatory Lead(m/w/x)
Garching bei München
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading projects for radiopharmaceuticals in cancer treatment, focusing on IND/CTA submissions and FDA/EMA interactions. 7-10 years experience with pharma/biotech submissions and health authority interactions, including direct FDA/EMA, required. Flexible hybrid work options.
Anforderungen
- Degree in pharmacy, chemistry, biochemistry, biotechnology, or related field
- 7–10 years of regulatory experience in pharma, biotech, or authorities
- Knowledge of pharmaceutical development and IND/CTA regulations
- Ability to integrate oncology drug regulations into development plans
- Experience in direct interactions with FDA and EMA
- Excellent English skills and optional German fluency
Aufgaben
- Expertly lead early-stage radiopharmaceutical development projects
- Focus on upcoming IND and CTA submissions
- Report directly to the Head of Clinical Regulatory Affairs
- Act as primary contact for the FDA and EMA
- Manage regulatory interactions and operational submissions
- Collaborate closely with subject matter experts and project teams
- Lead scientific Health Authority meetings and protocol assistance
- Oversee timely filing of original and amendment INDs and CTAs
- Develop global regulatory strategies for product candidates
- Align regulatory plans with clinical development objectives
- Identify risks and implement mitigation strategies
- Coordinate high-quality responses to Health Authority requests
- Optimize submission strategies using appropriate regulatory pathways
- Review and approve clinical and non-clinical documents
- Author product-specific briefing books and regulatory reports
- Provide proactive guidance to clinical trial teams
- Stay current with evolving global regulatory guidelines
- Support business development and departmental initiatives
Berufserfahrung
- 7 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- IND regulations
- CTA regulations
- FDA
- EMA
Benefits
Flexibles Arbeiten
- Hybrid working model
- Flexible working hours
- Home office options
Abwechslungsreiche Aufgaben
- Exciting challenges
Lockere Unternehmenskultur
- Creative freedom
- Open working atmosphere
- International corporate culture
- Short communication channels
Weiterbildungsangebote
- Comprehensive onboarding programme
- Individually tailored training programme
- German and English courses
Boni & Prämien
- Attractive special payments
Attraktive Vergütung
- Employee participation programme
Firmenfahrrad
- Job bike
Öffi Tickets
- Subsidised job ticket
Betriebliche Altersvorsorge
- Company pension scheme contribution
Gesundheits- & Fitnessangebote
- Health promotion programmes
- EGYM Wellpass
- Fitness studio subsidy
Team Events & Ausflüge
- Sponsorship of sporting events
Mentoring & Coaching
- Lifestyle coaching sessions
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ITM Isotope Technologies Munich SE 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
ITM Isotope Technologies Munich SE
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt, produziert und vertreibt zielgerichtete diagnostische und therapeutische Radiopharmazeutika sowie Radioisotope für die Krebsbehandlung.
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
Medical Affairs Manager(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGarching bei München - ITM Isotope Technologies Munich SE
Head of Early Pipeline Strategy(m/w/x)
Vollzeitmit HomeofficeManagementMünchen - Immatics Biotechnologies GmbH
Director Clinical Sciences(m/w/x)
Vollzeit/Teilzeitmit HomeofficeManagementTübingen, München