Regulatory CMC Director (Cell & Gene Therapy)

AstraZeneca • Gaithersburg, MD

1d • $186,232 - $279,349 • Hybrid

About The Position

This role positions you at the center of breakthrough programs, where your regulatory leadership translates pioneering science into high-quality submissions and decisive health authority interactions that accelerate access for people who need it most. Based in Santa Monica, CA or Gaithersburg, MD, you will shape end-to-end CMC regulatory pathways across development stages, partnering closely with technical, clinical, and quality leaders. You will apply your expertise to anticipate risk, set clear direction, and drive rapid, global approvals for a growing pipeline.

Requirements

• 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.
• Ability 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.
• MA/MS degree in life sciences required; advanced degree preferred (PhD, PharmD).
• Experience of 10+ years with BS/BA; 8+ years with MS/MA or MBA; 6+ years with PhD.
• Prior experience in cell/gene therapy.
• In depth knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies.
• Experience in IND, IMPD, BLA, MAA filings.

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• Support the development and maintenance of regulatory templates, best practices, and procedures that raise quality, consistency, and speed of execution across programs.
• Support hiring, lead workflow, and develop staff; build and guide high-functioning teams to deliver complex program milestones.
• Perform other duties as required, championing simplification and data-driven approaches that shorten development cycles and improve submission readiness.

Benefits

• Competitive salary and benefits package
• Short-term incentive bonus opportunity
• Equity-based long-term incentive program (salaried roles) or retirement contribution (hourly roles)
• Qualified retirement program (401(k) plan)
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director