Director, Regulatory Affairs - CMC (Cell Therapy)
Company: AstraZeneca
Location: Montgomery Village
Posted on: June 26, 2025
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Job Description:
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 AstraZenecas
Cell and Gene Therapies (CGT). This position may be based in Santa
Monica, CA or Gaithersburg, MDand 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 guidanceto 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, participateon 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. 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.
Keywords: AstraZeneca, Bel Air South , Director, Regulatory Affairs - CMC (Cell Therapy), Science, Research & Development , Montgomery Village, Maryland
