Director, CMC Regulatory Sciences
Core
Lead global CMC regulatory strategies and oversee a team responsible for the quality and timeliness of regulatory submissions across all modalities.
Role type
Director, CMC Regulatory Sciences
Builds
Regulatory submissions (IND/CTA through NDA/BLA) for biologics, small molecule, cell and gene therapy, and combination products.
Domain
Biopharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
CMC regulatory strategy, FDA/EMA/international regulations, team leadership, submission documentation, process improvement, regulatory intelligence, resource management, talent development
Preferred skills
Experience with multiple modalities, industry association representation
Technologies
None stated
Responsibilities
Lead and manage a team for CMC regulatory submissions; Develop and implement global CMC regulatory strategies; Direct preparation and review of CMC documentation; Build and improve team processes and workflows; Establish and track operational metrics; Interact with regulatory authorities; Manage team capacity and workload; Mentor and develop staff
Seniority
Director, strategic leadership and team management
