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
Managing product realization and preparing marketing approval submissions for personalized medicine diagnostics. Deep understanding of healthcare regulatory frameworks and 5+ years in related roles required. Global project scope, high autonomy.
Requirements
- Bachelor’s or Master’s degree in Life Science, Data Science, or related field, or equivalent experience
- At least 5 years of experience in Regulatory, R&D, Quality, Operations, and/or Clinical roles
- Ability to manage high-complexity work and/or global projects with minimal supervision
- Deep understanding of healthcare regulatory frameworks
- Agile mindset, adept at problem-solving, and skilled in effective communication and stakeholder management
Tasks
- Collaborate with internal and external stakeholders
- Manage project and product realization
- Identify and resolve regulatory issues
- Prepare submission packets for marketing approvals
- Interpret regulatory frameworks for strategy development
- Utilize agile principles to streamline activities
- Oversee development of submission and registration dossiers
- Troubleshoot and develop solutions for compliance issues
Work Experience
- 5 - 10 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
Managing product realization and preparing marketing approval submissions for personalized medicine diagnostics. Deep understanding of healthcare regulatory frameworks and 5+ years in related roles required. Global project scope, high autonomy.
Requirements
- Bachelor’s or Master’s degree in Life Science, Data Science, or related field, or equivalent experience
- At least 5 years of experience in Regulatory, R&D, Quality, Operations, and/or Clinical roles
- Ability to manage high-complexity work and/or global projects with minimal supervision
- Deep understanding of healthcare regulatory frameworks
- Agile mindset, adept at problem-solving, and skilled in effective communication and stakeholder management
Tasks
- Collaborate with internal and external stakeholders
- Manage project and product realization
- Identify and resolve regulatory issues
- Prepare submission packets for marketing approvals
- Interpret regulatory frameworks for strategy development
- Utilize agile principles to streamline activities
- Oversee development of submission and registration dossiers
- Troubleshoot and develop solutions for compliance issues
Work Experience
- 5 - 10 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 personalized medicine and improving patient lives through innovative diagnostics and healthcare solutions.
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