17d 15h ago
Regulatory Affairs Project Manager
Roche·Pharmaceuticals
🏢Hybrid
|Penzberg, Germanyproject_management
Regulatory Affairs Project Manager
Roche | Pharmaceuticals
2 weeks agoHybrid
Full Time
Germany, Penzberg, Mannheim, Sant Cugat del Vallès, Indianapolis
Source not independently verified — confirm the company domain before applying.
Position:
Regulatory Affairs Project Manager (m/f/d)
Company:
Roche
Location:
Germany, Penzberg or Mannheim or Sant Cugat del Vallès or Indianapolis
Employment type:
Full Time
Work Arrangement:
Hybrid
Short Summary:
At Roche, we are passionate about transforming patients’ lives and committed to scientific rigor and access to medical innovations. Join us in our mission to champion patient access to the world's best diagnostics.
Responsibilities:
- Provide strategic direction and representation of Regulatory Affairs in international and interdisciplinary teams.
- Manage product registrations in Europe, United States, and China.
- Prepare and submit premarket submissions to FDA or Notified body.
- Interact with regulatory agency personnel to expedite approval or clearance of pending registrations.
- Support product care activities and update technical documentation of the product portfolio.
Requirement:
- Bachelor’s or Master’s in Life Science, Data Science, or related subject.
- Minimum 5 years of experience in Regulatory, R&D, Quality, Operations, or Clinical.
- Technical understanding of medical devices or IVDs.
- Knowledge of international laws and regulations for IVDs, especially in EU, US, and China.
- Project management expertise in an agile environment.
- Excellent knowledge of English; additional language is an advantage.
Benefits:
- Open-minded work environment.
- Opportunities for personal and professional development.
- Collaborative relationships across departments and sites.
Regulatory Affairs Project Manager (m/f/d)
Company:
Roche
Location:
Germany, Penzberg or Mannheim or Sant Cugat del Vallès or Indianapolis
Employment type:
Full Time
Work Arrangement:
Hybrid
Short Summary:
At Roche, we are passionate about transforming patients’ lives and committed to scientific rigor and access to medical innovations. Join us in our mission to champion patient access to the world's best diagnostics.
Responsibilities:
- Provide strategic direction and representation of Regulatory Affairs in international and interdisciplinary teams.
- Manage product registrations in Europe, United States, and China.
- Prepare and submit premarket submissions to FDA or Notified body.
- Interact with regulatory agency personnel to expedite approval or clearance of pending registrations.
- Support product care activities and update technical documentation of the product portfolio.
Requirement:
- Bachelor’s or Master’s in Life Science, Data Science, or related subject.
- Minimum 5 years of experience in Regulatory, R&D, Quality, Operations, or Clinical.
- Technical understanding of medical devices or IVDs.
- Knowledge of international laws and regulations for IVDs, especially in EU, US, and China.
- Project management expertise in an agile environment.
- Excellent knowledge of English; additional language is an advantage.
Benefits:
- Open-minded work environment.
- Opportunities for personal and professional development.
- Collaborative relationships across departments and sites.
Required Skills
project_management
Required Languages
🇬🇧 English