Associate Director, Regulatory Affairs CMC (Cell & Gene Therapy)
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Job Location:
Gaithersburg, MD - USA
Monthly Salary:
$ 135182 - 202773
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
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 Responsibilities
Interpret 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 (e.g.CMCcomponent(s) 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 maintenance
You 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 teamsparticipateonand/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 events
Attention to detail.
Outstanding organizational skills with the ability to multi-task and prioritize.
Education and Experience
Experience ofa minimum of ten (10) years with aBachelorsdegree in life sciences or 8 years with aMastersdegree 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 were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres 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. Were on an exciting journey to pioneer the future of healthcare.
So whats next
Are you already imagining yourself joining our team Good because we cant wait to hear from you!
The annual base pay (or hourly rate of compensation) for this position ranges from $135182.40 - 202773.60 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). 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
22-Jan-2026Closing Date
05-Feb-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.
Required Experience:
Director
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
