Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSenior
Risch-Rotkreuz
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DEDeciphera Pharmaceuticals
Senior Manager, International Regulatory Affairs(m/w/x)
Zug
Full-timeOn-siteSenior
Nejo AI Summary
Submitting new Marketing Authorisation Applications internationally and managing post-approval lifecycle activities. Strong EU regulatory affairs experience required. Independent work in a matrixed environment, pragmatic communication.
Requirements
- Strong EU Regulatory Affairs experience
- Solid lifecycle management for marketed products
- Independent work in matrixed environment
- Clear, concise, pragmatic communication
- Strong relationship-building and stakeholder management
- Strong scientific background; PhD or advanced degree preferred
- International market exposure outside EU is a plus
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
- Bachelor'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-timeOn-siteSenior
Nejo AI Summary
Submitting new Marketing Authorisation Applications internationally and managing post-approval lifecycle activities. Strong EU regulatory affairs experience required. Independent work in a matrixed environment, pragmatic communication.
Requirements
- Strong EU Regulatory Affairs experience
- Solid lifecycle management for marketed products
- Independent work in matrixed environment
- Clear, concise, pragmatic communication
- Strong relationship-building and stakeholder management
- Strong scientific background; PhD or advanced degree preferred
- International market exposure outside EU is a plus
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
- Bachelor'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?
- Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Vaxcyte
Executive Director, Regulatory Affairs(m/w/x)
Full-timeFreelanceOn-siteSeniorZug, Visp - AstraZeneca
Senior Medical Affairs Leader, Breast(m/w/x)
Full-timeOn-siteSeniorBaar - Cytokinetics
Director, Regulatory Affairs CMC(m/w/x)
Full-timeOn-siteSeniorZug