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GRA CMC Lead at Sanofi - ApplyBlast

GRA CMC Lead

Sanofi

1 month ago

4.1 on Glassdoor

Toronto, Ontario, Canada

Onsite

Full Time

Senior

0 applicants

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About this role

The GRA CMC Lead manages a portfolio of projects and marketed products within the R&D team, focusing on global CMC regulatory strategy, variation approvals, and direct interactions with Health Authorities. This role involves collaborating with Global Regulatory Affairs, regional teams, quality groups, and partners to ensure effective regulatory compliance and strategic decision-making. The position requires developing lasting relationships with Health Authorities and supporting regulatory inspection processes.

Responsibilities

Develop CMC regulatory strategies and assess associated risks for development projects
Manage variation approvals and direct interactions with Health Authorities
Coordinate submission of CMC regulatory files and monitor post-approval commitments

Skills

Qualifications

BS/BA degree in a relevant scientific disciplinePharmDPhDMDDVM

About Sanofi

sanofi.com

Headquarters

Paris, Île-De-France, France

Company Size

10001+ employees

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Sanofi is a research & development-driven, AI-powered healthcare biopharma company committed to improving lives through innovative medicines & vaccines.