Director, Regulatory Affairs CMC — Cell Therapy

BrainChild Bio, Inc.; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

BrainChild Bio, Inc. is seeking a Director, Regulatory Affairs, CMC to lead global regulatory CMC strategy across clinical-stage cell therapy programs.

This role ensures that submissions are compliant and of high quality while aligning cross-functionally to advance programs toward patient access. You will drive Module 3 content, coordinate regulatory submissions (INDs, IMPDs, BLAs, MAAs, variations), and collaborate with development teams and external partners to ensure GMP compliance and

Qualifications

• 8+ years of Regulatory CMC and/or drug development experience.
• Experience supporting FDA-regulated cell therapy products.
• Familiarity with GMP principles and documentation practices.
• Excellent attention to detail and ability to manage multiple priorities.
• Strong cross-functional communication.

Responsibilities

• Lead regulatory CMC submissions (INDs, IMPDs, BLAs, MAAs, variations, amendments) for cell therapy programs.
• Develop global regulatory CMC strategies aligned with program objectives and requirements.
• Serve as Regulatory CMC lead on cross-functional teams, providing strategic guidance.
• Coordinate Module 3 content and ensure alignment across US, EU, and other authorities.
• Evaluate regulatory impact of CMC changes and define filing strategies.
• Identify regulatory risks and develop mitigation strategies for successful outcomes.
• Lead interactions with health authorities, prepare briefing packages and responses.
• Collaborate to ensure deliverables meet regulatory, quality standards, and timelines.
• Drive continuous improvement of Regulatory CMC processes.

Skills

Regulatory CMC experience

Cross-functional collaboration

Attention to detail

Regulatory submissions

Education

Bachelor’s degree in scientific discipline

Job description

BrainChild Bio, Inc. is seeking a Director, Regulatory Affairs, CMC to lead global regulatory CMC strategy across clinical-stage cell therapy programs.

This role ensures that submissions are compliant and of high quality while aligning cross-functionally to advance programs toward patient access. You will drive Module 3 content, coordinate regulatory submissions (INDs, IMPDs, BLAs, MAAs, variations), and collaborate with development teams and external partners to ensure GMP compliance and