Manager, Regulatory Affairs – CMC

Role Overview

• Lead all operational and lifecycle management aspects of Regulatory CMC submissions (e.g., INDs, IMPDs, BLAs, MAAs, variations, amendments) supporting global clinical and commercial CAR‑T programs
• Serve as the Regulatory CMC lead on assigned program and/or platform teams, applying advanced knowledge of global CMC regulatory requirements for autologous cell therapies
• Author, review, and coordinate Module 3 (M3) content, ensuring global alignment and harmonization across regions (US, EU, and other international health authorities)
• Develop and execute CMC regulatory strategies that align with overarching regulatory and business strategies, including support for global site additions, process changes, raw material changes, analytical updates, and shelf‑life extensions
• Proactively identify CMC regulatory risks and lead scenario planning, including anticipation of regulator questions and development of mitigation and contingency plans
• Assess and provide regulatory impact evaluations for CMC changes through formal change control processes, ensuring appropriate global regulatory strategies are defined and executed
• Support interactions with global health authorities by contributing to briefing packages, written responses, and regulatory meeting preparations specific to CMC topics
• Collaborate cross‑functionally to ensure CMC deliverables meet regulatory requirements, quality standards, and program timelines
• Support continuous improvement and best‑practice sharing for Regulatory CMC processes in a rapidly growing, dynamic environment

Requirements

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biology, Chemical Engineering, or related field) with 6 years of relevant Regulatory CMC and/or drug development experience, including direct experience with FDA-regulated products or a master's degree in related scientific discipline and 4 years of relevant experience as listed above.
• Experience supporting biologics and/or cell or gene therapy products is strongly preferred
• Experience with autologous CAR‑T cell therapy or advanced therapy medicinal products (ATMPs)
• Working knowledge of global regulatory requirements (FDA, EMA, and other international agencies)
• Experience supporting both clinical development and commercial lifecycle management

Benefits

• company-sponsored medical, dental, vision, and life insurance plans.
• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off