Director, Regulatory Affairs, CMC

BrainChild Bio

Director in Regulatory Affairs at BrainChild Bio leading CMC regulatory strategies for cell therapies. Ensuring quality, safety, and compliance for clinical-stage products.

Posted 7/15/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory CMC submissions and strategies, particularly for cell therapy products, while ensuring compliance with global regulatory requirements and quality standards. Proven ability to lead cross-functional teams and manage complex regulatory processes in a dynamic environment.

Highest-signal resume keywords

Regulatory CMC ExperienceCell Therapy DevelopmentGMP PrinciplesRegulatory Submission ManagementCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory CMC SubmissionsINDsIMPDsBLAsMAAsModule 3 Content AuthoringChange Control ProcessesFiling StrategiesRegulatory Risk MitigationTechnical Justifications

Soft Skills

Attention to DetailOrganizational SkillsEffective CommunicationAdaptabilityAbility to Manage Multiple Priorities

Industry Keywords

FDA RegulationsHealth AuthoritiesQuality StandardsContinuous ImprovementBest-Practice Sharing

About the role

Key responsibilities & impact

Lead all operational and lifecycle management aspects of Regulatory CMC submissions (e.g., INDs, IMPDs, BLAs, MAAs, variations, amendments) supporting cell therapy development programs.
Develop and execute global regulatory CMC strategies that align with program objectives, regulatory requirements, and overall business strategy.
Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development and lifecycle management.
Author, review, and coordinate Module 3 (M3) content, ensuring consistency, quality, and alignment across global regulatory submissions (e.g., US, EU, and other international health authorities).
Evaluate the regulatory impact of CMC changes through formal change control processes and define and execute appropriate filing strategies.
Proactively identify CMC regulatory risks, anticipate Health Authority questions, and develop mitigation and contingency strategies to support successful outcomes.
Lead or contribute to interactions with health authorities by preparing briefing packages, technical justifications, responses to information requests, and regulatory meeting support.
Collaborate cross‑functionally to ensure CMC deliverables meet regulatory requirements, quality standards, and program timelines.
Drive continuous improvement and best‑practice sharing for Regulatory CMC processes in a rapidly growing, dynamic environment.

Requirements

What you’ll need

Bachelor’s degree in scientific discipline (e.g., Chemistry, Biochemistry, Biology, Chemical Engineering, or related field).
8+ years of Regulatory CMC and/or drug development experience, including direct experience supporting FDA-regulated cell therapy products.
Familiarity with GMP principles and documentation practices.
Strong attention to detail, organizational skills, and ability to manage multiple priorities.
Effective communication skills and ability to work cross-functionally.
Ability to thrive in a fast-paced, mission-driven, small company environment and adapt to shifting priorities.

Benefits

Comp & perks

Occasional travel required.