Fresenius Kabi
Sr Director Head Of Global Regulatory Strategy(m/w/x)
Full-timeOn-siteManagement
Eysins
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
FRFresenius Kabi SwissBioSim GmbH
Director Global Regulatory Affairs Lead(m/w/x)
Eysins
VollzeitVor Ort
Nejo KI-Zusammenfassung
Shaping regulatory strategies for biosimilar development and managing health authority interactions. Independent execution and cross-functional coordination expected. Global team collaboration, 4-day work week.
Aufgaben
- Shape and drive regulatory strategies for biosimilar development
- Manage lifecycle and ensure efficient submissions and approvals
- Execute regulatory strategies independently and coordinate cross-functional activities
- Lead interactions with health authorities and implement feedback
- Influence the evolving regulatory landscape proactively
- Provide global regulatory leadership for biosimilar development
- Manage submission-related documents and data
- Prepare and execute meetings with health authorities (e.g., EMA, FDA)
- Develop and drive global submission strategies for biosimilar dossiers
- Ensure compliance with regulatory requirements in key markets (EU, US, Canada, Switzerland, Brazil)
- Align and gain endorsement of regulatory strategies with Development Team and BMT
- Define and deliver clear regulatory storylines for authority interactions
- Collaborate with Regulatory Operations to implement technologies
- Ensure consistent systems and processes
- Provide regulatory guidance to Market Units
- Support global launch and market prioritization decisions
- Lead the Regulatory Sub-team
- Drive submissions through to approval
- Conduct readiness assessments
- Act as key interface across regulatory and cross-functional teams
- Mentor team members
- Manage external partners
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Fresenius Kabi SwissBioSim GmbH 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.
Not a perfect match?
- Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs CMC(m/w/x)
Full-timeOn-siteSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
Full-timeOn-siteSeniorEysins - Fresenius Kabi SwissBioSim GmbH
VP Global Head of Supply Chain(m/w/x)
Full-timeOn-siteSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Regulatory Affairs Specialist Intern(m/w/x)
Full-timeInternshipOn-siteEysinsfrom CHF 60,000 / year
FRFresenius Kabi SwissBioSim GmbH
Director Global Regulatory Affairs Lead(m/w/x)
Eysins
VollzeitVor Ort
Nejo KI-Zusammenfassung
Shaping regulatory strategies for biosimilar development and managing health authority interactions. Independent execution and cross-functional coordination expected. Global team collaboration, 4-day work week.
Aufgaben
- Shape and drive regulatory strategies for biosimilar development
- Manage lifecycle and ensure efficient submissions and approvals
- Execute regulatory strategies independently and coordinate cross-functional activities
- Lead interactions with health authorities and implement feedback
- Influence the evolving regulatory landscape proactively
- Provide global regulatory leadership for biosimilar development
- Manage submission-related documents and data
- Prepare and execute meetings with health authorities (e.g., EMA, FDA)
- Develop and drive global submission strategies for biosimilar dossiers
- Ensure compliance with regulatory requirements in key markets (EU, US, Canada, Switzerland, Brazil)
- Align and gain endorsement of regulatory strategies with Development Team and BMT
- Define and deliver clear regulatory storylines for authority interactions
- Collaborate with Regulatory Operations to implement technologies
- Ensure consistent systems and processes
- Provide regulatory guidance to Market Units
- Support global launch and market prioritization decisions
- Lead the Regulatory Sub-team
- Drive submissions through to approval
- Conduct readiness assessments
- Act as key interface across regulatory and cross-functional teams
- Mentor team members
- Manage external partners
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Fresenius Kabi SwissBioSim GmbH 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
Fresenius Kabi SwissBioSim GmbH
Branche
Pharmaceuticals
Beschreibung
Fresenius Kabi is a global healthcare company that specializes in IV fluids and other critical care products.
Not a perfect match?
- Fresenius Kabi
Sr Director Head Of Global Regulatory Strategy(m/w/x)
Full-timeOn-siteManagementEysins - Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs CMC(m/w/x)
Full-timeOn-siteSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
Full-timeOn-siteSeniorEysins - Fresenius Kabi SwissBioSim GmbH
VP Global Head of Supply Chain(m/w/x)
Full-timeOn-siteSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Regulatory Affairs Specialist Intern(m/w/x)
Full-timeInternshipOn-siteEysinsfrom CHF 60,000 / year