Associate Director, Regulatory Affairs CMC

The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of Cell & Gene Therapies. This position is hybrid and based in Gaithersburg, MD and reports to the Senior Director, CMC Regulatory AffairsCGT.Essential Functions and ResponsibilitiesInterpret global regulations and guidance toidentifyrisks and provide input for guidance to cross functional product teams.You will partner with cross-functional stakeholders toauthor, review anddeliver regulatory dossiers ( of IND / IMPD / BLA/ Master Files, amendments, annual reports) and health authority interaction briefing documents.Manage regulatory dossiers throughout the product development lifecycle.Leadappropriate CMCteams. Ensure the delivery of submission documentation which is fit forthe intended purpose withappropriate considerationof the desire forsubsequentoperationalflexibility.Lead complex programs.Provide review and compilation and ensure thatsubmissiondocuments and correspondence are of the highest quality in terms 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 andparticipatein technical risk assessment exercises.Provide support for regulatory submissions, maintenanceYou will support the development and maintenance of regulatory templates, best practices, and procedures.AstraZeneca drives business performance through continuous improvement, we thereforeexpect all employeesto:1) Follow processes and work to standards, 2) Identify and solveproblems 3) Define and implement improvements. Leaders will lead by example in creating alearning & continuous improvement culture.Required Skills/Abilities Demonstrated ability to develop/maintainstrong working relationships with the cross functional teams,participateonand/or lead multi-functional teams, handle, and prioritize multiple projects and work independently.Excellent communication and collaboration skills to work in afast pacedstart up environment.Ability to deal with time demands, incompleteinformationor unexpected eventsAttention to detailrequired.Outstanding organizational skills with the ability to multi-task and prioritize.Education and ExperienceExperience ofa minimum of ten (10) years with aBachelor'sdegree in life sciences or 8 years with aMaster'sdegree or 6 years with a 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.Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.So, what’s next? Are you already imagining yourself joining our team? Good, because we can’t wait to hear from youDate Posted22-Jan-2026Closing Date05-Feb-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.