Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSenior
Risch-Rotkreuz
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RORoche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Risch-Rotkreuz
Full-timeOn-siteSenior
Data Science
Nejo AI Summary
Coordinating IVD submissions and health authority notifications at a diagnostics solutions provider. 5+ years in diagnostics or pharma regulatory affairs required; CDx experience a plus. Focus on innovative diagnostics solutions, global project scope.
Requirements
- Bachelor’s or Master’s degree in Life Science, Data Science, or related subject, or equivalent experience
- At least 5 years of experience in Regulatory, R&D, Quality, Operations, and/or Clinical
- Experience in diagnostics or pharmaceutical regulatory affairs
- Advanced degree and experience in CDx considered an advantage
- Ability to manage high complexity work and/or global projects, or equivalent experience
- Proven ability to work autonomously
Tasks
- Support high-quality regulatory submissions of IVDs
- Coordinate and compile submission documents on time
- Maintain regulatory approvals throughout the product lifecycle
- Manage health authority notifications and submissions
- Collaborate with functions, stakeholders, and external partners
- Provide input on project and product regulatory strategy
- Support international regulatory submissions with necessary data
- Respond to Health Authority inquiries regarding submissions
- Keep Affiliates informed about new products and process changes
- Ensure understanding and communication of regulatory requirements
Work Experience
- 5 - 7 years
Education
- Vocational certificationOR
- 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 Roche Diagnostics Int. AG 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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RORoche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Risch-Rotkreuz
Full-timeOn-siteSenior
Data Science
Nejo AI Summary
Coordinating IVD submissions and health authority notifications at a diagnostics solutions provider. 5+ years in diagnostics or pharma regulatory affairs required; CDx experience a plus. Focus on innovative diagnostics solutions, global project scope.
Requirements
- Bachelor’s or Master’s degree in Life Science, Data Science, or related subject, or equivalent experience
- At least 5 years of experience in Regulatory, R&D, Quality, Operations, and/or Clinical
- Experience in diagnostics or pharmaceutical regulatory affairs
- Advanced degree and experience in CDx considered an advantage
- Ability to manage high complexity work and/or global projects, or equivalent experience
- Proven ability to work autonomously
Tasks
- Support high-quality regulatory submissions of IVDs
- Coordinate and compile submission documents on time
- Maintain regulatory approvals throughout the product lifecycle
- Manage health authority notifications and submissions
- Collaborate with functions, stakeholders, and external partners
- Provide input on project and product regulatory strategy
- Support international regulatory submissions with necessary data
- Respond to Health Authority inquiries regarding submissions
- Keep Affiliates informed about new products and process changes
- Ensure understanding and communication of regulatory requirements
Work Experience
- 5 - 7 years
Education
- Vocational certificationOR
- 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 Roche Diagnostics Int. AG 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
Roche Diagnostics Int. AG
Industry
Healthcare
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone, with a focus on innovative diagnostics solutions.
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