New · posted Nov 5
AstraZeneca · Pharmaceuticals
Associate Director, Promotional Regulatory Affairs
- Gaithersburg, MD +1 more
- Hybrid
- Full-time
- Director
The role
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to help business teams develop and deliver initiatives that are intended to comply with applicable laws, rules and regulations governing the advertising and promotion of pharmaceutical products in the US. Lead review and adjudication of promotional materials as are required through the AstraZeneca Approval Process (AZAP). Represent AstraZeneca to regulatory authorities for assigned brand(s), and projects, as appropriate. Provide promotional regulatory advice and support to cross-functional partners in accordance with their respective strategies and objectives, as well as to provide current PRA interpretations and recommendations related to FDA promotional regulations and associated guidance.
Date Posted
04-Nov-2026
Closing Date
19-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.
What you need
Accountabilities
As the Associate Director Promotional Regulatory Affairs, you will ensure efficient and effective regulatory review and risk assessment of promotional material for all segments (HCP, Consumer, Managed Markets) and media (Print, broadcast and electronic), sales training, faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and any other materials required to be reviewed through AZAP. Conduct reviews within established timelines and meets expedited requests as priorities and workload allow. Assist in innovative regulatory strategy development and implementation, including risk identification and contingency planning.
You will participate with Commercial Operations, MLR reviewers, and asset owners in asset prioritization and consult meetings, as requested. Provide guidance to the business, as requested, to assist in implementation of Brand(s) strategy. Develop PRA guidance and job aids on relevant topics for use within the department and for use by cross-functional partners as appropriate
You will manage requests for FDA advisory review of materials and adjudication of incoming/outgoing competitor product complaints, as appropriate. Help to evaluate Brand(s) regulatory training needs, develop and deliver training in partnership with the Internal and/or External Training Initiative or PRA Skill Center. Monitor regulatory agency activities, new guidance, and emerging trends in the regulatory environment, and shares such information within PRA and the business, as appropriate.
Essential Skills / Experience
Bachelors Degree in pharmacy, pharmacology, life science, or related field or equivalent experience a plus
5 years’ experience in drug/biologic regulatory affairs or related pharmaceutical/biotech field
Working knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences
Working knowledge of the drug development process
Experience with electronic review and approval programs (VEEVA PromoMats or other) a plus
Desirable Requirements
Experience influencing decision-making of others
Experience in therapeutic areas of AZ focus
Pharmaceutical or biotech regulatory/compliance/commercial/medical affairs experience
Experience working in a team-based environment
Collaborative and solution-oriented mindset
Effective verbal and written communication and influencing skills
Exemplary compliance ethics and high concern for standards
Strategic and analytic thinking and decision-making skills
Ability to manage a diverse workload and quickly adjust to changing business priorities
Ability to manage, coordinate, and execute on projects independently with minimum supervision and in a timely manner
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca? Here you will connect scientific rigor with commercial execution to make meaningful change for patients. We move with pace and purpose, bringing together diverse perspectives to spark ideas that translate into real-world impact. With autonomy to act and leaders who create a safe space to experiment and learn, you will help define how modern promotion and compliance come together—pairing cutting-edge channels with sound judgment. Your contribution will shape how we launch and scale medicines, improve the patient journey, and develop as a leader alongside colleagues who value kindness as much as ambition.
Call to Action:
If you are ready to lead with clarity, anticipate risk, and enable bold, compliant storytelling that advances patient impact, step forward and help us raise the bar for promotional excellence!
The annual base pay for this position ranges from $150,098 to $225,147. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Pay and benefits
$150,098 – $225,147 a year
Employer providedQualified retirement programs
Paid time off
Health coverage
Dental coverage
Vision coverage
Short-term incentive bonus
Where you'll work
Gaithersburg, MD +1 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Wilmington, DE
More jobs in Gaithersburg, MD +1 moreJob intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 9% below the US median for Labeling & Promotion roles at this level.
This roleEmployer provided
Director roles in the US40 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $150,098 | — | $225,147 |
| All US (middle half) | $187,500 | $205,500 | $215,875 |
This role: AstraZeneca's own published range. Comparisons: the base pay employers published on open Labeling & Promotion roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Labeling & Promotion
The general path across 86 open Labeling & Promotion 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 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- GMP and compliance5
- Regulatory submissions2
- Quality systems and risk2
- Investigations and CAPA1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Labeling & Promotion work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDA21 CFR Part 202(official source, opens in a new tab)Prescription drug advertising: fair balance and required information
- FDAFDA OPDP(official source, opens in a new tab)The Office of Prescription Drug Promotion, which reviews advertising and promotion
- FDAFDA prescription drug labeling resources(official source, opens in a new tab)Physician Labeling Rule (PLR) format and content of prescribing information
- FDAFDA Structured Product Labeling(official source, opens in a new tab)The SPL standard for submitting labeling content to FDA
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- FDAFDA REMS(official source, opens in a new tab)Risk Evaluation and Mitigation Strategies for drugs with serious safety concerns
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- CMSOpen Payments (Sunshine Act)(official source, opens in a new tab)Reporting of manufacturer payments to physicians and teaching hospitals
- HHS-OIGHHS-OIG General Compliance Program Guidance(official source, opens in a new tab)The federal government's guide to healthcare compliance programs and the anti-kickback statute
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
AstraZeneca on Regulatory Jobs
- 38
- Open roles
- 35
- Distinct roles
- 11
- Locations
By discipline
- Quality15 39%
- Clinical14 37%
- Regulatory9 24%
By level
- Director21 55%
- Associate & Specialist11 29%
- Senior & Principal4 11%
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Associate Director, Promotional Regulatory Affairs at AstraZeneca
Applications close November 20. $150K–$225K a year, employer provided.