Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP)
Core
Lead global CMC regulatory strategy for biologics and ATMPs, ensuring alignment between regulatory plans, technical development, and manufacturing execution to drive timely approvals.
Role type
Senior management regulatory leader (Biologics/ATMP)
Builds
Global regulatory submissions and lifecycle management for biologics and ATMPs
Domain
Biotechnology / Pharmaceutical Regulatory Affairs
Required skills
Global CMC regulatory strategy, risk assessment and mitigation, Health Authority interaction, post-approval lifecycle management, cross-functional collaboration, governance decision-making
Preferred skills
Industry association engagement, global development and manufacturing network experience
Technologies
Regulatory submission platforms, CMC data management systems
Responsibilities
Lead CMC regulatory team in developing global strategies, assess regulatory risks, ensure submission readiness, guide interactions with Health Authorities, oversee post-approval changes, represent regulatory function in new product evaluations, participate in external industry forums, review and approve regulatory submissions
Seniority
Senior, strategic leadership & team management