New · posted Nov 10
AstraZeneca · Pharmaceuticals
Associate Director, CMC Regulatory Affairs (Cell & Gene Therapies)
- Cambridge, MA
- Hybrid
- Full-time
- Director
The role
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 may be based in Santa Monica, CA, Gaithersburg, MD or Boston, MA and reports to the Senior Director, CMC-CGT Regulatory Affairs.
What you need
Required 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 required.
- Outstanding organizational skills with the ability to multi-task and prioritize
- Experience of a minimum of 8 years with a Master's degree in life sciences or 6 years with a PhD.
- Prior experience in cell/gene therapy is preferred.
- Knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies.
- Experience in IND, IMPD, BLA, and MAA filings is preferred.
What you'll do
Essential Functions and 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.
- Support Reg CMC activities in 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.
- Deliver “submission ready” CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality
Supervisory Responsibilities
- Support hiring, leading workflow and development of staff.
Pay and benefits
$136,000 – $203,000 a year
Employer providedSo, what’s next?
Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.
Short-term incentive bonus
Equity-based long-term incentive program
401(k) retirement plan
Paid vacation and holidays
Paid leaves
Medical, prescription drug, dental and vision coverage
Where you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MA
From the posting
About AstraZeneca
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being ambitious - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking methods, and bringing unexpected teams together. Interested? Come and join our journey.
Date Posted
09-Nov-2026
Closing Date
15-Nov-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In 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.
Equal opportunity, accessibility and legal noticesAstraZeneca's statements, word for word
The annual base pay (or hourly rate of compensation) for this position ranges from $135,624.80 - $203,437.20 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 experience. In 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
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 19% below the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in Massachusetts14 roles publishing pay
Director roles in the US45 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $136,000 | — | $203,000 |
| Massachusetts (middle half) | $190,625 | $209,000 | $229,375 |
| All US (middle half) | $190,000 | $209,000 | $240,000 |
This role: AstraZeneca's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 86 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not AstraZeneca's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions7
- Collaboration and leadership7
- Documentation and SOPs5
- GMP and compliance4
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory CMC work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
- ICHICH Q11(official source, opens in a new tab)Development and manufacture of drug substances
- ICHICH Q12(official source, opens in a new tab)Lifecycle management of post-approval chemistry, manufacturing and controls changes
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- ICHICH M7(official source, opens in a new tab)Assessment and control of mutagenic impurities
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
Company hiring pulse
AstraZeneca on Regulatory Jobs
- 44
- Open roles
- 44
- Distinct roles
- 10
- Locations
By discipline
- Clinical18 41%
- Quality14 32%
- Regulatory12 27%
By level
- Director28 64%
- Associate & Specialist12 27%
- Senior & Principal2 5%
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Associate Director, CMC Regulatory Affairs (Cell & Gene Therapies) at AstraZeneca
Applications close November 16. $136K–$203K a year, employer provided.