Provide strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs
Develop and execute global CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management activities for biologic products
Serve as the primary CMC Regulatory Affairs representative on cross-functional teams
Drive CMC regulatory submissions and manage Health Authority interactions related to CMC topics
Assess regulatory risks and support successful product approvals and post-approval activities worldwide

Bachelor's degree in a scientific discipline (Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field)
7+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry
Significant CMC Regulatory Affairs experience
Experience supporting biologics development programs from early development through commercialization
Significant experience supporting Phase 3 and late-stage development programs
Experience supporting global regulatory submissions, including BLAs, MAAs, NDAs, INDs, IMPDs, and CTAs
Extensive experience leading CMC regulatory activities for biologic products
Experience supporting manufacturing process development and commercialization of biologic drug substances and drug products
Experience participating in and leading Health Authority interactions related to CMC topics
Experience supporting global post-approval change management

premium health
financial, work-life and well-being offerings for eligible employees and dependents
wellness and employee support programs
life insurance
disability
retirement plans with employer match
generous paid time off

Senior Manager, CMC Regulatory Affairs – Biologics

Key skills