Director, CMC Regulatory Affairs

The Director, CMC Regulatory Affairs is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position can be based in Santa Monica, CA, San Francisco, CA or Gaithersburg, MD and reports to the Executive Director, CMC Regulatory Affairs.

Responsibilities

•  Provide strategic guidance during all stages of product development and lead the development and implementation of global CMC regulatory strategies for the pipeline of AZ products.

• 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 and maintain regulatory dossiers as required throughout the product development lifecycle.

• Represent CMC regulatory affairs on product teams and in health authority interactions.

• Provide review and compilation and ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.

• 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.

• Perform other duties as required.

Supervisory duties 

• Support hiring, leading and managing workflow and development of staff.

Skills/Abilities 

• Demonstrated ability to develop/maintain strong working relationships with the 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.

Education and Experience

• Experience of 10+ years with BS/BA; 8+ years with MS/MA; 6+ years with PhD. Degree in life sciences required.

• 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.

#CellTherapy

The annual base pay for this position ranges from $173K to $260K. 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. Benefits offered include a qualified retirement program; 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. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

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, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.