Position Summary The Associate Director, CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies.
This position is hybrid, and may be based in Santa Monica, CA or Gaithersburg, MD and reports to the Executive Director, CMC Regulatory Affairs.
Responsibilities Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams.Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g.
CMC component(s) of IND / IMPD / BLA/ Master Files, amendments, annual reports) and health authority interaction briefing documents.
Manage regulatory dossiers throughout the product development lifecycle.Lead complex programs.Provide review and compilation and ensure that submission documents 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 and participate in technical risk assessment exercises.Support the development and maintenance of regulatory templates, best practices, and procedures.Supervisory Responsibilities Support hiring, leading workflow and development of staff.Build and lead high-functioning teams.Education and Experience Experience of 10+ years with a bachelor's degree in life sciences or 8+ years with a master's degree or 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.Salary and Benefits The annual base salary for this position ranges from $128,651 to $192,977, 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 and eligibility to participate in our equity-based long-term incentive program.
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.
Diversity and Inclusion AstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible.
We believe that the more inclusive we are, the better our work will be.
We welcome and consider applications from all qualified candidates, regardless of their characteristics.
Date Posted 20-Dec-2024
Closing Date 30-Jan-2025
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