Roche encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally
Job Summary
Roche encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
You will be responsible for preparation of high quality CMC regulatory documents for the products local/global in accordance with Roche corporate standards and the requirements of applicable health authorities in support of local/global filings.
You will contribute to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.
Matching Summary
Roche encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
Skills & Requirements
Must-have
CMC regulatory documents preparation
Regulatory submissions
Health authority interactions
Change control management
ICH, WHO, China regulations
Nice-to-have
Open dialogue and genuine connections
Personal expression and creativity
Continuous improvement initiatives
Cross-functional collaboration
Key Requirements
Master’s Degree in life science disciplines
3+ years pharmaceutical/biotech experience
Experience generating technical registration dossier for China/EU/USA