Director, Regulatory Affairs, CMC

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BrainChild Bio

WebsiteLinkedInAll Job Openings

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $300k Grant - BrainChild Bio on 2025-01

Biotechnology • Pharmaceuticals

<BrainChild Bio> is a clinical-stage biotechnology company developing CAR T-cell therapies targeting tumors in the central nervous system (CNS). The company prioritizes pediatric brain tumors while extending its platform to adult indications such as glioblastoma and brain metastases, aiming to advance novel cell therapies through the clinic and translate its science broadly to improve outcomes for children and adults with CNS cancers.

📋 Description

• 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

• 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

• Occasional travel required.