# Regulatory CMC Director (Cell & Gene Therapy) **Company**: CMC Regulatory Affairs **Location**: Gaithersburg, Maryland, United States of America **Work arrangement**: hybrid **Experience**: senior **Job type**: full-time **Salary**: Competitive salary and benefits package on offer **Category**: Engineering **Industry**: Healthcare **Apply**: https://astrazeneca.eightfold.ai/careers/job/563877690459289?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_9c892e5d-290 ## Description Are you ready to steer global CMC strategy for cell and gene therapies that redefine what’s possible for patients? 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. How will you apply your expertise to anticipate risk, set clear direction, and drive rapid, global approvals for a growing pipeline? **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. - 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. **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. **Why AstraZeneca:** Join a place where regulatory innovators have the tools and trust to move fast and think boldly. Here, unexpected teams gather in the same room to unlock smarter pathways, using data and modern approaches to minimize barriers and shorten development cycles. You will be part of a globally connected community that shares best practice, values kindness alongside ambition, and turns transformative science into real value for patients. With a rich pipeline and the autonomy to be an agent of change, your impact will be tangible,from shaping strategy to seeing rapid, global approvals reach people who need them. **Competitive salary and benefits package on offer:** Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. The annual base salary for this position ranges from $186,232 - 279,349. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. ## Skills ### Required - Regulatory leadership - Global CMC strategy - Regulatory intelligence and risk management - Dossier leadership and health authority engagement - Lifecycle management - Standards and ways of working - People leadership - Continuous improvement ### Nice to have - Direct experience leading health authority meetings - Expertise in CGT-specific comparability strategies - Familiarity with eCTD publishing tools - Track record delivering expedited pathways or accelerated approvals - Experience working across multiple sites - Comfort using analytics or automation --- Source: [Apply at astrazeneca.eightfold.ai](https://astrazeneca.eightfold.ai/careers/job/563877690459289?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)