New · posted Oct 28
AstraZeneca · Pharmaceuticals
Regulatory Affairs Director
- Cambridge, MA
- Hybrid
- Full-time
- Director
The role
Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?
At AstraZeneca, we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe.
The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.
What you need
Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.
A solid knowledge of regulatory affairs within at least one therapeutic area in both early and late development.
Previous demonstrated experience of regulatory drug development or equivalent, and experience with major HA interactions.
Demonstrated competencies of strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.
Preferred Qualificationsnice to have
Advanced degree preferred.
Experience in the development or application of radio-conjugates would be highly advantageous.
Experience in Oncology (small molecules & biologics) is preferred.
Prior experience with phase 3 design including end of phase 2 health authority interactions.
Contribution to a regulatory approval including leading response team and labeling negotiations.
Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
Ability to work strategically within a business critical and high-profile development program.
Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.
Next Steps – Apply today!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
What you'll do
Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with competitive labeling that is identified by the business, markets and patients.
Craft the health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.
Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Mentor and provide performance feedback to members of your GRST.
Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success. Lead preparation of the regulatory strategy document and target product labeling.
Own the negotiations with health authorities and initiate and deliver key regulatory documents.
Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities.
Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
Pay and benefits
$186,000 – $279,000 a year
Employer providedCompetitive salary and benefits package on offer
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.
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
Date Posted
27-Oct-2026
Closing Date
14-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 salary for this position ranges from $186,232.80 - 279,349.20. However, 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) or to receive a retirement contribution (hourly 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 salary (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 28, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in Massachusetts31 roles publishing pay
Director roles in the US104 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $186,000 | — | $279,000 |
| Massachusetts (middle half) | $218,000 | $232,500 | $264,000 |
| All US (middle half) | $212,125 | $236,750 | $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 28, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 310 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not AstraZeneca's own promotion track.
Career resources on Regulatory Affairs
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions11
- Collaboration and leadership8
- Documentation and SOPs3
- GMP and compliance2
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.
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
AstraZeneca on Regulatory Jobs
- 22
- Open roles
- 18
- Distinct roles
- 9
- Locations
By discipline
- Quality15 68%
- Regulatory7 32%
By level
- Associate & Specialist9 41%
- Director7 32%
- Senior & Principal4 18%
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Regulatory Affairs Director at AstraZeneca
Applications close November 15. $186K–$279K a year, employer provided.