Senior Manager - CMC RA Biopharm Development Projects
Core
Leading CMC regulatory activities for investigational, late development, and early commercial biopharmaceutical products to support global registration and lifecycle maintenance.
Role type
Senior Manager, CMC Regulatory Affairs
Builds
Regulatory submission packages (NDA/BLA/MAA) and strategies for global product approval
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
CMC regulatory strategy, global regulatory requirements interpretation, project management, risk mitigation, team leadership, regulatory document authoring
Preferred skills
Managing multiple complex projects, influencing regulatory agencies, major filing activities (MAA/NDA/BLA), manufacturing change management, supervising junior staff
Technologies
Regulatory submission systems, CMC compliance frameworks
Responsibilities
Drive CMC strategy and coordinate timely preparation of technical regulatory documents; Identify and communicate risk mitigation strategies for submission data; Mentor staff and manage project activities for multiple complex projects; Engage in CMC Subject Matter Expert activities internally and externally; Ensure CMC regulatory aspects for clinical trials and product release are in place; Formulate novel approaches to improve CMC regulatory processes; Direct communication of complex regulatory issues across the company and with external agencies
Seniority
Senior, hands-on IC with management responsibilities