Global CMC Regulatory Lead, Vaccines

Sanofi; Toronto; Vor Ort; CAD 109.000 - 157.000; Vollzeit

Zusammenfassung

Sanofi in Toronto, ON is seeking a GRA CMC Lead to manage a portfolio of development and/or marketed vaccine products, defining global CMC regulatory strategy and coordinating with Health Authorities. You will collaborate with Global Regulatory Affairs, regional teams, and internal functions to prepare submissions and monitor post-approval commitments.

The role requires 4+ years in regulatory CMC, a BS/BA in science, and an advanced degree is preferred.

Qualifikationen

• BS/BA degree in a relevant scientific discipline required, e.g., Biology, Chemistry or Life sciences.
• Advanced degree (PharmD, PhD, MD or DVM or MSc) preferred.

Aufgaben

• Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products.
• Participate in Change Control assessment.
• Guarantee strong collaboration within CMC teams for the implementation of defined regulatory strategies.
• Ensure that for CMC activities with a major regulatory and/or financial impact, appropriate strategies are implemented and risks identified.
• Develop relationships with Health Authorities and support strategic negotiations with the FDA and EMA.
• Coordinate submission of CMC regulatory files and review in collaboration with R&D and Industrial Affairs.

Kenntnisse

Regulatory strategy

Change control

Cross-functional collaboration

Health Authority liaison

Communication skills

Ausbildung

BS/BA in science

Advanced degree preferred

Jobbeschreibung

Sanofi in Toronto, ON is seeking a GRA CMC Lead to manage a portfolio of development and/or marketed vaccine products, defining global CMC regulatory strategy and coordinating with Health Authorities. You will collaborate with Global Regulatory Affairs, regional teams, and internal functions to prepare submissions and monitor post-approval commitments.

The role requires 4+ years in regulatory CMC, a BS/BA in science, and an advanced degree is preferred.