This role is critical in bridging site operations with global regulatory strategies to ensure compliance while enabling innovation
Job Summary
This role is critical in bridging site operations with global regulatory strategies to ensure compliance while enabling innovation.
The successful candidate will author and maintain Chemistry, Manufacturing, and Controls (CMC) documentation for global and local regulatory submissions.
Responsibilities include managing responses to Health Authority queries and conducting regulatory impact assessments for site changes.
Matching Summary
Match Score: 75
This role is critical in bridging site operations with global regulatory strategies to ensure compliance while enabling innovation.
Skills & Requirements
Must-have
CMC documentation authoring
Global regulatory submissions
Health Authority query management
Change impact assessments
ICH EMA FDA PMDA WHO guidelines
Nice-to-have
Veeva Vault proficiency
eCTD submission systems
Continuous improvement mindset
Cross-functional collaboration skills
Key Requirements
Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or Life Sciences
Minimum 2 years experience in Regulatory Affairs with CMC focus
Experience with global regulatory submissions and country-specific filings