Director Promotional Regulatory Affairs

AstraZeneca•Gaithersburg, MD

1d•Hybrid

About The Position

The Director of Promotional Regulatory Affairs sets US promotional regulatory strategy and guardrails to enable responsible growth and trusted communication with healthcare professionals, consumers, and payers. The role partners with Medical, Legal, Commercial, and Corporate Affairs to shape claims early, guide labeling implications, and ensure promotional materials meet regulatory standards across print, broadcast, digital, and omnichannel media. It also uses FDA engagement and regulatory expertise to anticipate risk and inform sound strategy. The role leads promotional review and risk assessment, advises business leadership and brand teams, provides US-impact input to global teams, and serves as the primary liaison with OPDP/APLB for assigned brands. It develops training and guidance, monitors regulatory developments, contributes to PRA strategy and operational plans, and represents the company as a subject matter expert. The position also manages, develops, and mentors less experienced staff. The work is in-person an average of at least three days per week, with flexibility to accommodate individual needs.

Requirements

Bachelor’s degree in science.
At least 3 years of experience in promotional regulatory affairs, FDA (OPDP/APLB), or equivalent experience in advertising and promotion review.
At least 5 years of total experience in the pharmaceutical/biotech industry, FDA, or equivalent experience.
Strong knowledge of FDA promotional regulations and ability to apply that knowledge when reviewing diverse promotional materials and audiences.
Knowledge of drug development and labeling processes.

Nice To Haves

Advanced degree in life sciences, pharmacy, law, or a related discipline.
10 or more years of US promotional regulatory affairs experience within biopharma, including direct OPDP/APLB interactions and resolution of advisory or enforcement matters.
Experience leading or co-chairing MLR processes and working with 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 regulatory training for commercial and medical stakeholders.
Demonstrated ability to influence senior leaders and shape departmental practices and operational plans.
People leadership experience, including coaching and building high-performing teams.

Responsibilities

Drive efficient and effective regulatory review and risk assessment for promotional materials across HCP, Consumer, and Managed Markets segments and media types, including sales and faculty training, scientific exchange, and Corporate Affairs communications.
Lead the development and implementation of regulatory strategies, including risk identification and contingency planning.
Collaborate with MLR planners, reviewers, and asset owners on prioritization and consultation; advise business leadership on brand strategy and alignment of claims and evidence with regulatory expectations.
Provide global teams with input on how proposed TPP/TPC/TPL documents, labeling, studies, and corporate initiatives may affect US promotion, and provide clear guidance to US stakeholders.
Serve as primary liaison with OPDP/APLB for assigned brands; manage requests for FDA advisory review, address enforcement actions, and adjudicate competitor product complaints.
Evaluate brand regulatory training needs and develop and deliver training with internal or external Learning teams or the PRA Skill Center.
Follow and enhance established processes and guidelines; develop PRA guidance documents and job aids to improve clarity, speed, and review quality.
Monitor regulatory agency activities, guidance, and emerging trends, and share their implications with PRA and cross-functional partners.
Contribute to PRA vision, practices, operational plans, team objectives, and continuous improvement.
Manage, develop, and mentor less experienced staff and serve as a role model for performance and ways of working.
Represent the company internally and externally as a promotional regulatory affairs subject matter expert.