---
title: 'Director, Regulatory Affairs, CMC at BrainChild Bio'
canonical: 'https://feeny.ai/job/director-regulatory-affairs-cmc-brainchild-bio-united-states-bfdygs7y3wgm'
type: 'job'
last_seen: '2026-09-15'
---

# Director, Regulatory Affairs, CMC at BrainChild Bio

- **Company:** BrainChild Bio
- **Location:** United States
- **Employment:** full-time
- **Work type:** remote
- **Posted:** 2026-07-15
- **Last confirmed live:** 2026-09-15
- **Apply:** https://jobs.lever.co/brainchildbio/c7bfcdf2-83b1-4fdb-95c8-3d45ccf4ca41

## Job description

BrainChild Bio is seeking a Director, Regulatory Affairs, CMC, to support implementation of the global regulatory CMC strategy across our clinical-stage cell therapy programs. BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases, and this role plays a critical part in ensuring that every product delivered meets the highest standards of quality, safety, and reliability.

The Director, Regulatory Affairs, CMC is accountable for executing on the global CMC regulatory strategies across multiple products. This role contributes to the planning, preparation, and submission of regulatory CMC documentation. The individual will be expected to provide guidance to the program teams and will be responsible for preparation of CMC and Quality related agency correspondences and regulatory applications ensuring all applicable regulatory requirements are considered and appropriately incorporated into the lifecycle of each program.

The ideal candidate is detail-oriented, highly organized, and motivated by the opportunity to make a direct impact on patients’ lives. This role offers the opportunity to work cross-functionally with development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, and global health authorities.

Responsibilities: 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 of 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.

Qualifications: 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. Occasional travel required.

## About BrainChild Bio

## Company Overview
- **One-liner**: BrainChild Bio is a clinical-stage biotech company developing CAR-T cell therapies for central nervous system (CNS) tumors, with an initial focus on the childhood cancer DIPG.
- **Entity Type**: Private (funding stage not publicly disclosed)
- **Headquarters**: Seattle, WA, USA
- **Founded**: Not publicly available (launched out of Seattle Children’s, built on Dr. Michael Jensen’s research)
- **Founders**: Dr. Michael Jensen (Founder & Chief Scientific Officer)

## Core Business
- **Primary industry**: Biopharmaceuticals / Cell Therapy / Oncology
- **Target customers**: Pediatric and adult cancer patients, clinical partners, regulatory agencies, healthcare providers
- **Mission**: To develop safe and effective therapies for children with brain cancer — “we must get more cures to kids with cancer” ([brainchildbio.com - Careers](https://brainchildbio.com/careers/))

## Products & Services
- **BCB-276**: Clinical candidate for DIPG (diffuse intrinsic pontine glioma), an incurable childhood brainstem cancer; plan is to proceed directly to a single pivotal registrational trial designed to support a Biologics License Application (BLA) after FDA alignment ([brainchildbio.com - Pipeline](https://brainchildbio.com/pipeline/))
- **CNS CAR-T Platform**: Integrates synthetic technologies with three pillars — multiplexed targeting, potency enhancement, and remote control — to optimize CAR-T therapies for CNS tumors ([brainchildbio.com - About](https://brainchildbio.com/about/))
- **Expanding Pipeline**: Future planned expansion to other pediatric and adult brain tumors, including glioblastoma and brain metastases ([brainchildbio.com - Pipeline](https://brainchildbio.com/pipeline/))

## Market Standing
- **Valuation/Market Cap**: Not disclosed
- **Key Metric**: Total funding not publicly available; key milestone is FDA alignment to proceed with a pivotal registrational trial for BCB-276 ([brainchildbio.com - Pipeline](https://brainchildbio.com/pipeline/))
- **Notable Investors/Partners**: Not publicly available; company is closely tied to Seattle Children’s and the research legacy of Dr. Michael Jensen ([brainchildbio.com - About](https://brainchildbio.com/about/))
- **Growth Signals**: Clinical advancement to pivotal trial, active hiring across process development, regulatory affairs, and supply chain, and an expanding leadership team ([jobs.lever.co](https://jobs.lever.co/brainchildbio), [brainchildbio.com - Team](https://brainchildbio.com/team/))

## Competitive Advantages
- Built on over a decade of translational research, including FDA-authorized INDs covering four CNS CAR-T cell products ([brainchildbio.com - About](https://brainchildbio.com/about/))
- Deep specialty in CNS tumors — a difficult niche where established CAR-T approaches face unique challenges
- Mission-driven “kids first” positioning, leading to distinct patient-centric drug development priorities
- Proprietary platform combining multiplexed targeting, potency enhancement, and remote control technologies ([brainchildbio.com - About](https://brainchildbio.com/about/))

## Strategic Focus
- Accelerate BCB-276 through a pivotal registrational trial and toward BLA submission ([brainchildbio.com - Pipeline](https://brainchildbio.com/pipeline/))
- Expand the platform to additional CNS tumors in adults and children
- Build a best-in-class team across immunology, synthetic biology, manufacturing sciences, translational medicine, and clinical development ([brainchildbio.com - Team](https://brainchildbio.com/team/))

## Why Work Here
- **Culture**: Strong mission and values explicitly labeled “Kids First,” “Inventive,” and “Team” ([brainchildbio.com - Careers](https://brainchildbio.com/careers/))
- **Work Environment**: Offers hybrid and remote roles (e.g., remote Process Engineer; hybrid Scientist roles in Seattle) ([jobs.lever.co](https://jobs.lever.co/brainchildbio))
- **Unique Impact**: Rare opportunity to help advance therapies for pediatric brain cancer “that other biotechnology companies have not done” ([brainchildbio.com - Careers](https://brainchildbio.com/careers/))
- **Hiring Transparency**: AI tools may support aspects of the hiring process, but final decisions are made by humans ([jobs.lever.co](https://jobs.lever.co/brainchildbio))

## Sources
1. [brainchildbio.com - About Us](https://brainchildbio.com/about/)
2. [brainchildbio.com - Careers](https://brainchildbio.com/careers/)
3. [jobs.lever.co - BrainChild Bio](https://jobs.lever.co/brainchildbio)
4. [brainchildbio.com - Pipeline](https://brainchildbio.com/pipeline/)
5. [brainchildbio.com - Team](https://brainchildbio.com/team/)

## Other roles at BrainChild Bio

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- [Director, CMC Quality](https://feeny.ai/job/director-cmc-quality-brainchild-bio-united-states-a6p3vfnntz9p) — United States
- [Process Engineer](https://feeny.ai/job/process-engineer-brainchild-bio-seattle-76qqgdq51jsz) — Seattle, WA
- [Senior Manager, Supply Chain Planning & Operations](https://feeny.ai/job/senior-manager-supply-chain-planning-operations-brainchild-bio-seattle-aj74jj1swfr2) — Seattle, WA
- [Clinical Research Associate (CRA)](https://feeny.ai/job/clinical-research-associate-cra-brainchild-bio-united-states-d6d04t96sgtw) — United States
- [Senior Scientist - Process Development](https://feeny.ai/job/senior-scientist-process-development-brainchild-bio-seattle-120893rm0yk9) — Seattle, WA