Cytokinetics
Director, Regulatory Affairs, Europe(m/w/x)
Full-timeFreelanceWith HomeofficeSenior
Zug
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DEDeciphera Pharmaceuticals
Senior Manager, International Regulatory Affairs(m/w/x)
Zug
Full-timeWith Home OfficeSenior
Nejo AI Summary
Submitting new Marketing Authorisation Applications internationally and managing post-approval lifecycle activities. Strong EU regulatory affairs experience required. Collaboration with health authorities and global/local teams.
Requirements
- Strong EU Regulatory Affairs experience
- Solid lifecycle management for marketed products
- Independent work in matrixed environment
- Clear, concise, pragmatic communication
- Strong relationship-building skills
- Strong stakeholder-management skills
- Strong scientific background
- PhD or advanced scientific degree preferred
- International market exposure outside EU (plus)
- Swiss, EU/EFTA national or valid Swiss permit
Tasks
- Support regulatory strategy execution in EU and International markets
- Prepare and submit new Marketing Authorisation Applications (MAAs) internationally
- Manage post-approval lifecycle activities for marketed products
- Handle variations, renewals, and related procedures
- Collaborate with Health Authorities and global/local teams
- Build strong relationships with local partners and internal stakeholders
- Represent regional regulatory needs in global cross-functional teams
Work Experience
- approx. 4 - 6 years
Education
- 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 Deciphera Pharmaceuticals 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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DEDeciphera Pharmaceuticals
Senior Manager, International Regulatory Affairs(m/w/x)
Zug
Full-timeWith Home OfficeSenior
Nejo AI Summary
Submitting new Marketing Authorisation Applications internationally and managing post-approval lifecycle activities. Strong EU regulatory affairs experience required. Collaboration with health authorities and global/local teams.
Requirements
- Strong EU Regulatory Affairs experience
- Solid lifecycle management for marketed products
- Independent work in matrixed environment
- Clear, concise, pragmatic communication
- Strong relationship-building skills
- Strong stakeholder-management skills
- Strong scientific background
- PhD or advanced scientific degree preferred
- International market exposure outside EU (plus)
- Swiss, EU/EFTA national or valid Swiss permit
Tasks
- Support regulatory strategy execution in EU and International markets
- Prepare and submit new Marketing Authorisation Applications (MAAs) internationally
- Manage post-approval lifecycle activities for marketed products
- Handle variations, renewals, and related procedures
- Collaborate with Health Authorities and global/local teams
- Build strong relationships with local partners and internal stakeholders
- Represent regional regulatory needs in global cross-functional teams
Work Experience
- approx. 4 - 6 years
Education
- 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 Deciphera Pharmaceuticals 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.
About the Company
Deciphera Pharmaceuticals
Industry
Pharmaceuticals
Description
Deciphera Pharmaceuticals is a company focused on international accounting and US GAAP reporting.
Not a perfect match?
- Cytokinetics
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