Fresenius Kabi
Sr Director Head Of Global Regulatory Strategy(m/w/x)
Full-timeOn-siteManagement
Eysins
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FRFresenius Kabi SwissBioSim GmbH
Director Global Regulatory Affairs Lead(m/w/x)
Eysins
Full-timeOn-site
Nejo AI Summary
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.
Tasks
- 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
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi SwissBioSim GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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FRFresenius Kabi SwissBioSim GmbH
Director Global Regulatory Affairs Lead(m/w/x)
Eysins
Full-timeOn-site
Nejo AI Summary
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.
Tasks
- 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
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi SwissBioSim GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Fresenius Kabi SwissBioSim GmbH
Industry
Pharmaceuticals
Description
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