Associate Director, CMC Regulatory Affairs (Cell & Gene Therapies)
About The Position
The Associate Director, Regulatory Affairs, CMC – Cell & Gene Therapies (CGT) supports the development and successful performance of CMC regulatory strategy for AstraZeneca’s Cell & Gene Therapies pipeline. This hybrid position may be based in Santa Monica, California; Gaithersburg, Maryland; or Boston, Massachusetts, and reports to the Senior Director, CMC-CGT Regulatory Affairs. The role partners with cross-functional teams to develop, review, compile, and manage regulatory dossiers and health authority interaction materials throughout product development. It provides regulatory input on complex programs, manufacturing changes, quality compliance, technical risks, and evolving global requirements. The position also supports regulatory best practices, procedures, and templates, and delivers submission-ready CMC modules in accordance with applicable company systems and procedures. The Associate Director also supports hiring, workflow leadership, and staff development. The position requires strong cross-functional collaboration, communication, organization, prioritization, and leadership skills in a fast-paced environment.
Requirements
- At least 8 years of experience with a Master's degree in life sciences, or at least 6 years of experience with a Ph.D.
- Knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies.
- Ability to develop and maintain strong working relationships with cross-functional teams, participate in and/or lead multifunctional teams, manage and prioritize multiple projects, and work independently.
- Excellent communication and collaboration skills for a fast-paced environment.
- Leadership skills to lead complex programs and build and lead high-functioning teams.
- Ability to manage time demands, incomplete information, or unexpected events.
- Strong attention to detail.
- Outstanding organizational skills and ability to multitask and prioritize.
Nice To Haves
- Prior experience in cell or gene therapy.
- Experience with IND, IMPD, BLA, and MAA filings.
Responsibilities
- Interpret global regulations and guidance, identify risks, and provide input to cross-functional product teams.
- Partner with cross-functional stakeholders to deliver regulatory dossiers, including CMC components of IND, IMPD, BLA, and Master File submissions, amendments, annual reports, and health authority interaction briefing documents.
- Manage regulatory dossiers throughout the product development lifecycle.
- Support CMC regulatory activities in complex programs.
- Review and compile submission documents and correspondence to ensure high standards of content, organization, clarity, and accuracy.
- Represent CMC Regulatory Affairs on product teams and in health authority interactions.
- Provide regulatory assessments for manufacturing changes and quality compliance, and participate in technical risk assessment exercises.
- Support development and maintenance of regulatory templates, best practices, and procedures.
- Deliver submission-ready CMC modules to internal and external regulatory stakeholders in compliance with relevant company systems and procedures.
- Support hiring, lead workflow, and contribute to staff development.
Benefits
- Qualified retirement program (401(k) plan).
- Paid vacation and holidays.
- Paid leaves.
- Medical, prescription drug, dental, and vision coverage.
- Short-term incentive bonus opportunity.
- Eligibility to participate in the equity-based long-term incentive program for salaried roles.
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What This Job Offers
Job Type
Full-time
Career Level
Director
