Regulatory Manager Contractor - CMC

Regulatory Documentation & Submissions:

• 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.

Change Control & Compliance Support:

• 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.

Cross-functional Collaboration:

• 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.