Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Vollzeitmit HomeofficeSenior
München
Neuer Job?Nejo!
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ALAlnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
München
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading negotiations with German health authorities for RNAi-based medicines at biotech developing genetic disease treatments. 10+ years Regulatory Affairs experience in pharma/biotech with German health authority negotiation success required. Hybrid work model.
Anforderungen
- University degree in Life Sciences, related field, or advanced degree
- 10+ years Regulatory Affairs experience in pharma or biotech
- Success in regulatory negotiations and German health authority relationships
- Deep understanding of German regulatory environment and compliance standards
- Ability to lead cross-functional teams and influence stakeholders
- Excellent communication and fluency in German and English
- High initiative, resilience, and adaptability
- Willingness to travel as needed
Aufgaben
- Translate global regulatory strategies into German market execution
- Advise the General Manager and senior leadership on strategy
- Anticipate regulatory trends to position the company for success
- Develop actionable business plans and risk mitigation strategies
- Lead negotiations and meetings with German health authorities
- Manage regulatory planning for local product launches
- Oversee national submissions including PZN codes and RMP materials
- Approve promotional and medical materials for local compliance
- Provide regulatory input for supply chain and quality operations
- Implement regulatory systems to ensure operational excellence
- Represent regulatory interests in local cross-functional forums
- Partner with external consultants and industry stakeholders
- Participate in local industry associations to shape legislation
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Hybrid work model
Lockere Unternehmenskultur
- Inclusive recruitment process
Sonstige Vorteile
- Equal employment opportunity
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Alnylam Pharmaceuticals, Inc. 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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ALAlnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
München
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading negotiations with German health authorities for RNAi-based medicines at biotech developing genetic disease treatments. 10+ years Regulatory Affairs experience in pharma/biotech with German health authority negotiation success required. Hybrid work model.
Anforderungen
- University degree in Life Sciences, related field, or advanced degree
- 10+ years Regulatory Affairs experience in pharma or biotech
- Success in regulatory negotiations and German health authority relationships
- Deep understanding of German regulatory environment and compliance standards
- Ability to lead cross-functional teams and influence stakeholders
- Excellent communication and fluency in German and English
- High initiative, resilience, and adaptability
- Willingness to travel as needed
Aufgaben
- Translate global regulatory strategies into German market execution
- Advise the General Manager and senior leadership on strategy
- Anticipate regulatory trends to position the company for success
- Develop actionable business plans and risk mitigation strategies
- Lead negotiations and meetings with German health authorities
- Manage regulatory planning for local product launches
- Oversee national submissions including PZN codes and RMP materials
- Approve promotional and medical materials for local compliance
- Provide regulatory input for supply chain and quality operations
- Implement regulatory systems to ensure operational excellence
- Represent regulatory interests in local cross-functional forums
- Partner with external consultants and industry stakeholders
- Participate in local industry associations to shape legislation
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Hybrid work model
Lockere Unternehmenskultur
- Inclusive recruitment process
Sonstige Vorteile
- Equal employment opportunity
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Alnylam Pharmaceuticals, Inc. 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
Alnylam Pharmaceuticals, Inc.
Branche
Pharmaceuticals
Beschreibung
The company has led the RNAi Revolution and develops innovative medicines to treat diseases at their genetic source.
Noch nicht perfekt?
- Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
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