Director Promotional Regulatory Affairs

AstraZeneca•Gaithersburg, MD

30d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.