

New · posted Nov 5
AstraZeneca · Pharmaceuticals
Director Promotional Regulatory Affairs
- Gaithersburg, MD +1 more
- Hybrid
- Full-time
- Director
The role
Are you ready to steer US promotional regulatory strategy in a way that accelerates responsible growth and earns patient and prescriber trust? This role translates science into clear, compliant communication across healthcare professionals, consumers, and payers—so that what we say is as strong as the medicines we deliver.
As Director of Promotional Regulatory Affairs, you will set the regulatory guardrails that enable confident brand execution and speed. You will partner closely with Medical, Legal, Commercial, and Corporate Affairs to shape claims early, guide labeling implications, and ensure promotional materials meet the highest standards across all channels—from print and broadcast to digital and omnichannel. Your expertise with FDA engagement will help anticipate risk and convert it into sound strategy.
Do you thrive where fast decisions matter and your judgment sets the pace for launch and lifecycle excellence? Join a high-energy, commercially savvy environment that develops leaders who know how the enterprise runs and what excellence looks like in bringing innovation to patients.
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
- Regulatory Promotion Review: Drive efficient and effective regulatory review and risk assessment for promotional materials across HCP, Consumer, and Managed Markets segments and all media types, including sales and faculty training, scientific exchange, and Corporate Affairs communications, through established systems.
- Risk and Strategy Leadership: Lead innovative regulatory strategy development and implementation, including risk identification and contingency planning that safeguard brands while enabling bold, compliant storytelling.
- Cross-Functional Partnership: Collaborate with MLR planners, reviewers, and asset owners on asset prioritization and consultation; advise business leadership on Brand strategy to ensure claims and evidence align with regulatory expectations.
- Global Input for US Impact: Provide input to global teams on how proposed TPP/TPC/TPL documents, labeling, studies, and corporate initiatives may affect US promotion; translate insights into clear guidance for US stakeholders.
- External Agency Engagement: Serve as primary liaison with OPDP/APLB for assigned brands; manage requests for FDA advisory review, address enforcement actions, and adjudicate incoming/outgoing competitor product complaints to protect brand integrity.
- Training and Capability Building: Evaluate brand regulatory training needs and develop and deliver training in partnership with internal/external Learning teams or the PRA Skill Center, building regulatory acumen across the business.
- Process Excellence: Follow and enhance established processes and guidelines; develop PRA guidance documents and job aids that increase clarity, speed, and quality in review and approval.
- Intelligence and Foresight: Monitor regulatory agency activities, guidance documents, and emerging trends; distill and share implications with PRA and cross-functional partners to inform proactive planning.
- Departmental Contribution: Shape PRA vision, practices, and operational plans; contribute to team objectives and priorities with a focus on measurable outcomes and continuous improvement.
- People Leadership and Mentorship: Act as a role model for performance and ways of working; manage, develop, and mentor less experienced staff to elevate team capability.
- Subject Matter Representation: Represent the company as a subject matter expert internally and externally, reinforcing credibility and thought leadership in promotional regulatory affairs.
Essential Skills/Experience
- Bachelor’s degree in science
- 3+ years’ experience in promotional regulatory affairs, FDA (OPDP/APLB), or other equivalent experience in advertising and promotion review
- 5+ years total experience in pharmaceutical/biotech industry, FDA, or equivalent experience
- Strong knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences
- Knowledge of the drug development and labeling processes
Desirable Skills/Experience
- Advanced degree in life sciences, pharmacy, law, or a related discipline
- 10 or more years of experience in US promotional regulatory affairs within biopharma, including direct OPDP/APLB interactions and resolution of advisory or enforcement matters
- Experience leading or co-chairing MLR processes and operating within digital review systems such as AZAP or comparable platforms
- Launch-to-lifecycle leadership across HCP and consumer promotions, managed markets materials, and omnichannel/digital campaigns
- Proven ability to design and deliver effective regulatory training for commercial and medical stakeholders
- Demonstrated influence at senior levels to shape departmental practices and operational plans
- People leadership experience with a track record of coaching and building high-performing teams
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!
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
Director roles in the US40 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $187,500 | $205,500 | $215,875 |
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 12 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- Regulatory submissions4
- GMP and compliance2
- Documentation and SOPs2
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Labeling & Promotion work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA OPDP(official source, opens in a new tab)The Office of Prescription Drug Promotion, which reviews advertising and promotionNamed in the posting
- 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 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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Director Promotional Regulatory Affairs at AstraZeneca
Applications close November 20.


