Director, Regulatory Affairs CMC - Biologics

We are seeking an experienced Director, Regulatory Affairs CMC – Biologics to provide strategic and operational regulatory leadership across the biologics product lifecycle. As a senior leader and subject‐matter expert, you will lead and manage all CMC regulatory activities for biologics programs across the product lifecycle, oversee CMC components of regulatory submissions, and act as the CMC regulatory SME, advising project teams on strategy, risk, and key decision points.

Requirements

• Post‐secondary degree in biological, pharmaceutical, chemical, engineering sciences, or a related field
• 10–15 years of direct CMC Regulatory Affairs experience, with a strong focus on biologics
• Hands‐on experience authoring and/or reviewing Module 3, and leading or supporting health authority interactions
• Proven leadership experience and/or regulatory consulting background

Benefits

• Comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
• Medical, dental, and vision care
• Paid parental leave
• Paid caregiver leave
• Backup dependent care
• Adoption assistance
• Infertility coverage
• Family building support
• Behavioral health solutions
• Professional development resources
• Mentorship programs
• Employee resource groups
• Volunteer activities