The Director, Regulatory Affairs - CMC (CGT) is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of AstraZeneca's Cell and Gene Therapies (CGT). This position may be based in Santa Monica, CA or Gaithersburg, MD and reports to the Senior Director, CMC Regulatory Affairs (CGT).  

 

Essential Functions and 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 cell and gene 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. 

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

Perform other duties as required. 

Education & Experience

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. 

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 

Attention to detail and outstanding organizational skills with the ability to multi-task and prioritize. 

#CellTherapy #LI-Hybrid

The annual base pay for this position ranges from 186,232.80 - 279,349.20 USD. 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 included 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. 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.

Date Posted

02-May-2025

Closing Date

13-Jul-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.