Regulatory CMC Director (Cell & Gene Therapy)

Accountabilities

• Global CMC Strategy: Provide strategic guidance during all stages of product development and lead the development and implementation of global CMC regulatory strategies for cell and gene therapy programs, enabling efficient approvals and risk-mitigated plans.
• Regulatory Intelligence and Risk Management: Interpret global regulations and guidance to identify risks and provide clear, actionable input to cross-functional product teams; deliver regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessments.
• Dossier Leadership and Health Authority Engagement: Partner with stakeholders to deliver CMC components of IND, IMPD, BLA, Master Files, amendments, and annual reports; develop health authority briefing documents; represent CMC regulatory affairs on product teams and in agency interactions; ensure submission quality, clarity, and accuracy.
• Lifecycle Management: Manage and maintain regulatory dossiers throughout the product lifecycle, ensuring timely updates and robust documentation strategies that support development, scale-up, and post-approval changes.
• Standards and Ways of Working: Support the development and maintenance of regulatory templates, best practices, and procedures that raise quality, consistency, and speed of execution across programs.
• People Leadership: Support hiring, lead workflow, and develop staff; build and guide high-functioning teams to deliver complex program milestones.
• Continuous Improvement: Perform other duties as required, championing simplification and data-driven approaches that shorten development cycles and improve submission readiness.

Essential Skills/Experience

• Demonstrated ability to develop/maintain strong working relationships with cross-functional teams, participate on and/or lead multi-functional teams, handle and prioritize multiple projects, and work independently.
• Excellent communication and collaboration skills to work in a fast-paced start-up environment.
• Proficient leadership skills to successfully lead complex programs.
• Able to effectively build and lead high-functioning teams.
• Able to deal with time demands, incomplete information or unexpected events.
• Attention to detail required.
• Outstanding organizational skills with the ability to multi-task and prioritize.

Desirable Skills/Experience

• Direct experience leading health authority meetings and negotiating CMC strategies with multiple regions.
• Expertise in CGT-specific comparability strategies, potency assays, and control strategy development.
• Familiarity with eCTD publishing tools and document management systems.
• Track record delivering expedited pathways or accelerated approvals.
• Experience working across multiple sites and in highly matrixed, high-growth environments.
• Comfort using analytics or automation to streamline regulatory processes and enhance submission quality.