New · posted Oct 14
AstraZeneca · Pharmaceuticals
Regulatory Affairs Director - Oncology
- Gaithersburg, MD
- On-site
- Full-time
- Director
Closes Oct 16, 2026 · 3 days left
The role
Do you want to shape the future of oncology medicines and influence regulatory decisions that impact patients globally?
At AstraZeneca, we are driven by our commitment to advancing science and delivering life-changing medicines. As a Regulatory Affairs Director, you will play a pivotal role in defining and executing US regulatory strategies that accelerate innovation and bring transformative oncology therapies to patients worldwide.
This is an opportunity to lead complex regulatory initiatives across development, submission, approval and lifecycle management activities while partnering with leading scientists, clinicians and commercial teams across a global matrix environment.
What success looks like
In this role, you will:
- Deliver critical regulatory milestones for Oncology that support programme progression and approvals.
- Build productive relationships with health authorities and key internal stakeholders.
- Provide strategic leadership across complex, high-profile development programmes.
- Influence decisions that drive patient access to innovative medicines in the US market.
You will join a culture that values curiosity, courage and collaboration, where talented individuals are empowered to challenge convention and shape the future of healthcare. We invest in our people through meaningful career development, global mobility opportunities, leadership programmes and cutting-edge scientific innovation.
What you need
- Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or a related scientific discipline
- Significant experience within Regulatory Affairs, Regulatory Strategy and/or drug development in the pharmaceutical or biotechnology industry.
- Strong experience supporting regulatory strategies across early and late-stage development programmes.
- Experience with regulatory submissions and agency interactions, including INDs, NDAs and/or BLAs.
- Demonstrated ability to lead complex cross-functional initiatives and influence key stakeholders.
- Outstanding communication, strategic thinking and problem-solving skills.
- Experience operating effectively in a global matrix environment.
Preferred qualificationsnice to have
- Oncology regulatory experience.
- Advanced degree (MS, PharmD, PhD, MD or equivalent).
- Experience leading regulatory strategies through pivotal development milestones and health authority interactions.
- Prior involvement in regulatory approvals, response teams and labelling negotiations.
What you'll do
As Regulatory Affairs Director, you will provide strategic and operational regulatory leadership for assigned development programmes and marketed products. You will serve as a Regional US Regulatory Lead for the Oncology programme.
Key responsibilities include
- Developing and implementing regional regulatory strategies that support rapid approvals and competitive product labelling.
- Leading major regulatory submissions, including INDs, NDAs and BLAs.
- Driving regulatory agency engagement strategies and leading health authority interactions.
- Leading cross-functional US Oncology Regulatory Strategy teams, clinical development, CMC, labelling and regional regulatory functions.
- Assessing regulatory risks and developing mitigation strategies to support programme success.
- Influencing global product strategy through regulatory expertise and scientific insight.
- Leading preparation of regulatory strategy documents, briefing packages and target labelling.
- Representing AstraZeneca in discussions with global health authorities and external stakeholders.
Ready to make an impact?
Join AstraZeneca and help deliver the next generation of medicines that transform the lives of patients around the world.
Apply today to become part of a team where science, innovation and collaboration drive meaningful change.
Pay and benefits
$186,232 – $279,349 a year
Employer providedAstraZeneca is committed to providing competitive, equitable and transparent compensation.
The annual base pay for this position ranges from $186,232 - $279,349 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.
Short-term incentive bonus
Equity-based long-term incentive program
401(k) plan
Paid vacation and holidays
Paid leaves
Medical, prescription drug, dental and vision coverage
Where you'll work
Gaithersburg, MDOn-siteOpen in Maps (opens in a new tab)
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From the posting
About AstraZeneca
Why AstraZeneca?
At AstraZeneca, we follow the science and put patients first.
Our Oncology business continues to redefine what is possible in cancer treatment, creating opportunities for regulatory leaders to influence some of the most exciting programmes in the industry.
Date Posted
13-Oct-2026
Closing Date
15-Oct-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
Inclusion & Diversity
AstraZeneca is an equal opportunity employer committed to fostering an inclusive and diverse workplace. We welcome applications from all qualified candidates and make employment decisions without regard to legally protected characteristics.
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.
Job intelligence
The context around this role
Live data · October 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in Maryland6 roles publishing pay
Director roles in the US67 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $186,232 | — | $279,349 |
| Maryland (middle half) | $232,500 | $232,500 | $257,625 |
| All US (middle half) | $219,750 | $244,000 | $264,000 |
This role: AstraZeneca's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 201 open Regulatory Affairs 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 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership11
- Regulatory submissions10
- Documentation and SOPs1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
AstraZeneca on Regulatory Jobs
- 13
- Open roles
- 12
- Distinct roles
- 6
- Locations
By discipline
- Regulatory11 85%
- Quality2 15%
By level
- Director10 77%
- Manager2 15%
- Associate & Specialist1 8%
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Regulatory Affairs Director - Oncology at AstraZeneca
Applications close October 16. $186K–$279K a year, employer provided.