Manager/Director, Techinical Regulatory
Roche(1 month ago)
About this role
A Regulatory Affairs CMC specialist at Roche is responsible for preparing and coordinating regulatory documentation to support product registrations and ensure alignment with local, regional, and corporate requirements. The role contributes to regulatory strategy and approvals, liaises with health authorities as needed, and serves as a resource for less experienced colleagues.
Required Skills
- CMC Documentation
- Regulatory Strategy
- Dossier Preparation
- Change Control
- Labeling
- Health Authority Interaction
- Quality Systems
- Stakeholder Communication
- Compliance Monitoring
- Analytical Development
Qualifications
- Master's Degree in Life Science
About Roche
roche.comAs a pioneer in healthcare, we have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally.
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