AstraZeneca
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, Maryland, United States of America · Director
Sponsorship not specified$186k-$279kDetected 1 day ago
Product ManagementFDA RegulatoryCRISPRLeadershipCommunicationCollaborationOrganizational SkillsRegulatory Affairs
About the role
- Are you ready to steer global CMC strategy for cell and gene therapies that redefine what's possible for patients?
- 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.
Responsibilities
- 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.
- 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.
- How will you apply your expertise to anticipate risk, set clear direction, and drive rapid, global approvals for a growing pipeline?
Requirements
- Perform other duties as required, championing simplification and data-driven approaches that shorten development cycles and improve submission readiness.
Skills
- 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.
- Direct experience leading health authority meetings and negotiating CMC strategies with multiple regions.
Compensation
- The annual base salary for this position ranges from $186,232 - 279,349.
Equal opportunity
- If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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This listing is sourced directly from AstraZeneca's careers page and normalized into a canonical job model.