Regulatory CMC Director (Cell & Gene Therapy)

AstraZeneca • Santa Monica, CA

1d • $186,232 - $279,349 • Hybrid

About The Position

The Regulatory CMC Director will shape end-to-end CMC regulatory pathways for cell and gene therapy programs across development stages. The role provides strategic direction, anticipates regulatory risks, and leads global strategies intended to support efficient approvals. The position may be based in Santa Monica, California; Gaithersburg, Maryland; or Boston, Massachusetts, with employees expected to work face-to-face in an office three days per week.

The Director partners with technical, clinical, quality, and other cross-functional stakeholders to develop and implement global CMC regulatory strategies, interpret regulations and guidance, and assess manufacturing changes and quality compliance. The role leads CMC dossier components and health authority engagement, maintains regulatory documentation throughout the product lifecycle, and supports templates, best practices, procedures, and continuous improvement. It also supports hiring, leads workflow, and develops staff and high-functioning teams.

The role requires a life sciences MA/MS degree, with an advanced degree preferred, and substantial relevant experience based on degree level. Prior cell and gene therapy experience, in-depth knowledge of global CMC regulations and health authority expectations, and experience with IND, IMPD, BLA, and MAA filings are required. The position offers a stated annual base salary range of $186,232–$279,349, a short-term incentive bonus opportunity, and benefits subject to applicable terms and conditions.

Requirements

• MA/MS degree in life sciences required; advanced degree preferred (PhD, PharmD).
• Experience of 10+ years with a BS/BA; 8+ years with an MS/MA or MBA; or 6+ years with a PhD.
• Prior experience in cell and gene therapy.
• In-depth knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies.
• Experience with IND, IMPD, BLA, and MAA filings.
• Ability to build and maintain strong cross-functional working relationships; participate on or lead multifunctional teams; handle and prioritize multiple projects; and work independently.
• Excellent communication and collaboration skills for a fast-paced startup environment.
• Leadership skills to lead complex programs and build and lead high-functioning teams.
• Ability to manage time demands, incomplete information, and unexpected events.
• Attention to detail.
• Strong organizational skills and ability to multitask and prioritize.

Nice To Haves

• Direct experience leading health authority meetings and negotiating CMC strategies across 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 global CMC regulatory strategy development and implementation for cell and gene therapy programs.
• Interpret global regulations and guidance, identify risks, and provide 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, and ensure submission quality, clarity, and accuracy.
• Manage and maintain regulatory dossiers throughout the product lifecycle, including timely updates and documentation strategies that support development, scale-up, and post-approval changes.
• Support development and maintenance of regulatory templates, best practices, and procedures.
• Support hiring, lead workflow, develop staff, and build and guide high-functioning teams.
• Perform other duties as required and champion simplification and data-driven approaches to shorten development cycles and improve submission readiness.

Benefits

• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage, subject to applicable plan terms and conditions.
• Short-term incentive bonus opportunity.
• Eligibility to participate in an equity-based long-term incentive program for salaried roles.

What This Job Offers

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