Director, Regulatory Affairs CMC-Biologics
AmerisourceBergenCanada
Posted April 1, 2026
Full Time
About the Company
On August 30, 2023, AmerisourceBergen became Cencora. Cencora is a leading global pharmaceutical solutions organization centered on improving the lives of people and animals around the world. We partner with pharmaceutical innovators across the value chain to facilitate and optimize market access to therapies. Care providers depend on us for the secure, reliable delivery of pharmaceuticals, healthcare products, and solutions. Previously known as AmerisourceBergen, our new name, Cencora, unites our 46,000+ team members under one identity in pursuit of a shared purpose: We are united in our responsibility to create healthier futures. : We are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #11 on the Fortune 500 and #24 on the Global Fortune 500 with more than $200 billion in annual revenue.
Job Description
Cencora is seeking a Director, Regulatory Affairs CMC-Biologics to provide strategic and operational regulatory leadership across the biologics product lifecycle. The successful candidate will lead and manage all CMC Regulatory files, oversee regulatory submissions, and facilitate agency meetings and consulting services.
Requirements
- B.Sc. / M.Sc. degree in life sciences
- 10-15 years direct CMC experience in Regulatory Affairs with a clear focus on biologics
- Leadership skills and/or consulting experience
- Effective project and people management skills
- Strategic planning and problem-solving skills
- Knowledge of Health Canada and FDA regulations and guidance's related to the CMC regulatory landscape
Benefits
- Comprehensive suite of benefits focusing on physical, emotional, financial, and social aspects of wellness
- Medical, dental, and vision care
- Backup dependent care
- Adoption assistance
- Infertility coverage
- Family building support
- Behavioral health solutions
- Paid parental leave
- Paid caregiver leave
- Training programs
- Professional development resources
- Mentorship programs
- Employee resource groups
- Volunteer activities
