Regulatory Manager Contractor - CMC

The Manager, Regulatory CMC is responsible for supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to the development and commercialization of the company’s product. This role works closely with cross-functional teams to compile and maintain high-quality regulatory submissions.

Requirements

• Contribute to the preparation, review, and coordination of CMC sections for global regulatory submissions
• Assist with compiling technical data from Manufacturing, QA, and QC teams to support submissions
• Maintain and track regulatory submission timelines and deliverables
• Support responses to health authority information requests related to CMC topics
• Review and assess change controls to determine potential regulatory impact and filing requirements
• Maintain awareness of relevant regulatory guidance, ICH guidelines, and agency expectations for cell/gene therapies
• Help ensure documentation and submissions meet current regulatory standards and internal quality requirements
• Collaborate effectively with cross-functional partners in Process Development, Manufacturing, QA, QC, and Regulatory Affairs
• Participate in project team meetings and provide CMC regulatory support under the guidance of senior regulatory staff
• Assist with developing or revising SOPs, working instructions, and templates used in Regulatory CMC activities
• Participate in the organization of regulatory archives and tracking systems for submission history and regulatory documentation