Director, Regulatory Affairs CMC — Cell Therapy Strategy

BrainChild Bio, Inc.; Seattle (WA); On-site; USD 170,000 - 230,000; Full time

Job summary

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

You will guide program teams, prepare CMC and quality-related agency communications, and ensure compliance with regulatory requirements across lifecycle. The ideal candidate has 8+ years in Regulatory CMC, hands-on experience with FDA-regulated cell therapies, GMP practices, and strong cross-functional collaboration skills; occasional

Qualifications

• Bachelor’s degree in a scientific discipline.
• 8+ years of Regulatory CMC and/or drug development experience with FDA-regulated cell therapy products.
• Familiarity with GMP principles and documentation practices.
• Strong attention to detail and ability to manage multiple priorities.
• Effective cross-functional communication.
• Willingness to travel occasionally.

Responsibilities

• Lead all Regulatory CMC submissions and lifecycle management for cell therapy programs.
• Develop and execute global regulatory CMC strategies aligned with program goals.
• Serve as Regulatory CMC lead on cross-functional teams delivering strategic guidance.
• Author and coordinate Module 3 content for global submissions (US, EU, others).
• Evaluate CMC changes through change control and filing strategies.
• Identify regulatory risks and develop mitigation and contingency plans.
• Prepare briefing packages and responses for Health Authority interactions.
• Collaborate with teams to ensure regulatory deliverables meet requirements and timelines.
• Drive continuous improvement of Regulatory CMC processes in a growing company.

Skills

Attention to detail

Organizational skills

Cross-functional collaboration

Communication skills

Adaptability

Prioritization

Education

Bachelor's degree in sciences

Job description

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

You will guide program teams, prepare CMC and quality-related agency communications, and ensure compliance with regulatory requirements across lifecycle. The ideal candidate has 8+ years in Regulatory CMC, hands-on experience with FDA-regulated cell therapies, GMP practices, and strong cross-functional collaboration skills; occasional