Senior Director, Regulatory Affairs CMC

Role Overview

• Define and lead global CMC regulatory strategy for CAR‑T programs across early and late clinical development and post‑approval lifecycle management
• Anticipate evolving global expectations for ATMPs/CAR‑T and proactively assess regulatory risks, opportunities, and mitigation strategies
• Represent Regulatory CMC as a senior leader on cross‑functional governance and core teams
• Provide executive oversight and critical review of Module 3 / Quality content for clinical and commercial applications
• Ensure end‑to‑end consistency, scientific rigor, and regulatory defensibility of CMC dossiers, including in‑context review of compiled applications and health‑authority responses (e.g., RTQs, IRs)
• Serve as a senior CMC subject‑matter expert for health authority interactions, including briefing documents and participation in agency meetings
• Lead global CMC regulatory assessments for manufacturing and control changes, including process evolution, site transfers, comparability strategies, analytical changes, and shelf‑life updates
• Drive lifecycle strategies that balance regulatory compliance, technical feasibility, supply continuity, and business objectives
• Oversee complex global LCM planning, including sequencing, regional differences, and submission pathways
• Provide strategic regulatory guidance to technical teams throughout product development, scale‑up, validation, and commercialization
• Partner closely with Manufacturing, MSAT, Quality, and external CDMOs to ensure regulatory‑compliant execution
• Review and provide oversight of CMC components supporting labeling, product information, and related regulatory documents
• Lead, develop, and mentor a team of Regulatory CMC leaders and/or provide strong matrix leadership across programs
• Set priorities and oversee resources, and timelines for a complex portfolio of submissions and lifecycle activities
• Contribute to the advancement of Regulatory CMC capabilities, processes, and best practices globally

Requirements

• 14 years of biopharmaceutical industry experience, including extensive Regulatory CMC leadership with a bachelor's degree or 12 years with a master's degree
• Advanced degree preferred (PhD, PharmD, MS, or equivalent) in a scientific discipline
• Deep experience with cell therapy and/or gene therapy products; CAR‑T experience strongly preferred
• Demonstrated success leading global CMC strategies and major submissions (e.g., late‑stage clinical, BLA/MAA, post‑approval supplements)
• Strong knowledge of ICH guidelines, ATMP regulations, and global CMC expectations (FDA, EMA, and key international markets)

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