Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Vollzeitmit HomeofficeSenior
München
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
ITITM Isotope Technologies Munich SE
Senior Manager, Early Development Regulatory Lead(m/w/x)
Garching bei München
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Regulatory expert for early-stage radiopharmaceutical development, focusing on IND/CTA submissions and direct FDA/EMA interactions. Profound knowledge of oncology drug development regulations required. Flexible working hours, home office options, and employee participation programme.
Anforderungen
- Completed Bachelor's or Master's degree in pharmacy, chemistry, biochemistry, biotechnology, or related field; post-graduate degree is an advantage
- Profound knowledge and hands-on experience with regulatory requirements for pharmaceutical development, with a strong focus on IND and CTA regulations applicable to clinical development
- Ability to understand, interpret, and strategically integrate oncology drug development regulations and guidelines into comprehensive development plans; experience with radiopharmaceuticals is a strong asset
- Experience in direct interactions with regulatory authorities, particularly FDA and EMA
- Excellent written and spoken English skills; fluency in German is a plus
Aufgaben
- Serve as Regulatory Affairs expert for early-stage development projects
- Focus on upcoming IND/CTA submissions
- Report directly to the Head of Clinical Regulatory Affairs
- Act as primary regulatory contact with key Health Authorities (FDA, EMA)
- Hold operational accountability for regulatory interactions and submissions
- Collaborate closely with subject matter experts and the Global Project Team
- Lead preparation and conduct of scientific Health Authority meetings
- Oversee timely preparation, submission, and approval of filings (INDs, CTAs)
- Develop and implement global regulatory strategies for product candidates
- Align strategies with clinical development plans and program objectives
- Plan, organize, and manage regulatory activities
- Identify and mitigate risks for complex radiopharmaceutical products
- Coordinate timely, high-quality responses to Health Authority requests
- Optimize submission strategies using appropriate regulatory pathways
- Provide regulatory input, review, and approval of key documents
- Review and approve study protocols, Investigator’s Brochure, and reports
- Author and review high-quality, product-specific regulatory documents
- Collaborate with cross-functional experts on regulatory documents
- Ensure compliance with regional regulatory requirements
- Provide proactive regulatory guidance to clinical trial teams
- Maintain strong cross-functional stakeholder collaboration
- Stay current with evolving regulatory guidelines
- Support non-program-specific initiatives (e.g., business development, training)
Berufserfahrung
- 7 - 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – ist ein Plus
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Flexible working hours
- Home office options
Boni & Prämien
- Attractive special payments
Attraktive Vergütung
- Employee participation programme
Firmenfahrrad
- Job bike
Öffi Tickets
- Subsidised job ticket
Betriebliche Altersvorsorge
- Above-average company pension scheme contribution
Weiterbildungsangebote
- Individually tailored further training programme
- German courses
- English courses
Gesundheits- & Fitnessangebote
- Health promotion programmes
- EGYM Wellpass
- Subsidy for local fitness studio
Gemeinnützige Ausrichtung
- 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.
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ITITM Isotope Technologies Munich SE
Senior Manager, Early Development Regulatory Lead(m/w/x)
Garching bei München
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Regulatory expert for early-stage radiopharmaceutical development, focusing on IND/CTA submissions and direct FDA/EMA interactions. Profound knowledge of oncology drug development regulations required. Flexible working hours, home office options, and employee participation programme.
Anforderungen
- Completed Bachelor's or Master's degree in pharmacy, chemistry, biochemistry, biotechnology, or related field; post-graduate degree is an advantage
- Profound knowledge and hands-on experience with regulatory requirements for pharmaceutical development, with a strong focus on IND and CTA regulations applicable to clinical development
- Ability to understand, interpret, and strategically integrate oncology drug development regulations and guidelines into comprehensive development plans; experience with radiopharmaceuticals is a strong asset
- Experience in direct interactions with regulatory authorities, particularly FDA and EMA
- Excellent written and spoken English skills; fluency in German is a plus
Aufgaben
- Serve as Regulatory Affairs expert for early-stage development projects
- Focus on upcoming IND/CTA submissions
- Report directly to the Head of Clinical Regulatory Affairs
- Act as primary regulatory contact with key Health Authorities (FDA, EMA)
- Hold operational accountability for regulatory interactions and submissions
- Collaborate closely with subject matter experts and the Global Project Team
- Lead preparation and conduct of scientific Health Authority meetings
- Oversee timely preparation, submission, and approval of filings (INDs, CTAs)
- Develop and implement global regulatory strategies for product candidates
- Align strategies with clinical development plans and program objectives
- Plan, organize, and manage regulatory activities
- Identify and mitigate risks for complex radiopharmaceutical products
- Coordinate timely, high-quality responses to Health Authority requests
- Optimize submission strategies using appropriate regulatory pathways
- Provide regulatory input, review, and approval of key documents
- Review and approve study protocols, Investigator’s Brochure, and reports
- Author and review high-quality, product-specific regulatory documents
- Collaborate with cross-functional experts on regulatory documents
- Ensure compliance with regional regulatory requirements
- Provide proactive regulatory guidance to clinical trial teams
- Maintain strong cross-functional stakeholder collaboration
- Stay current with evolving regulatory guidelines
- Support non-program-specific initiatives (e.g., business development, training)
Berufserfahrung
- 7 - 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – ist ein Plus
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Flexible working hours
- Home office options
Boni & Prämien
- Attractive special payments
Attraktive Vergütung
- Employee participation programme
Firmenfahrrad
- Job bike
Öffi Tickets
- Subsidised job ticket
Betriebliche Altersvorsorge
- Above-average company pension scheme contribution
Weiterbildungsangebote
- Individually tailored further training programme
- German courses
- English courses
Gesundheits- & Fitnessangebote
- Health promotion programmes
- EGYM Wellpass
- Subsidy for local fitness studio
Gemeinnützige Ausrichtung
- 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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 - Denk Pharma GmbH & Co. KG
Manager Regulatory Affairs für Deutschland & die EU(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenMünchen - ITM Isotope Technologies Munich SE
GPMO Project Manager & CMC Lead(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München - ITM Isotope Technologies Munich SE
Director, Global Medical Affairs - Publications(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München - ITM Isotope Technologies Munich SE
Head of Clinical Operations(m/w/x)
Vollzeitmit HomeofficeSeniorGarching bei München