Director Promotional Regulatory Affairs

AstraZeneca•Gaithersburg, MD

6d•Hybrid

About The Position

The Director of Promotional Regulatory Affairs leads US promotional regulatory strategy and review to support responsible growth and build patient and prescriber trust. The role sets regulatory guardrails for brand execution and partners with Medical, Legal, Commercial, and Corporate Affairs to shape claims, guide labeling implications, and ensure promotional materials meet applicable standards across print, broadcast, digital, and omnichannel channels. The Director provides regulatory review and risk assessment for promotional materials across healthcare professional, consumer, and managed markets audiences, as well as training, scientific exchange, and Corporate Affairs communications. The role develops regulatory strategy and contingency plans; advises business leaders on brand strategy and alignment of claims and evidence with regulatory expectations; and provides global teams with input on implications for US promotion. The position serves as the primary liaison with OPDP/APLB for assigned brands, including managing FDA advisory review requests, addressing enforcement actions, and handling competitor product complaints. It also builds organizational capability through training, improves review processes and guidance, monitors regulatory developments, contributes to PRA department plans, mentors staff, and represents the company as a promotional regulatory affairs subject matter expert. The role is based on an in-person working model, with an average minimum of three days per week in the office and flexibility in balancing office attendance with 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 to review 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 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 using 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

Drive efficient and effective regulatory review and risk assessment of promotional materials across HCP, Consumer, and Managed Markets segments and media types, including sales and faculty training, scientific exchange, and Corporate Affairs communications.
Lead development and implementation of regulatory strategies, including risk identification and contingency planning.
Collaborate with MLR planners, reviewers, and asset owners on asset prioritization and consultation; advise business leadership on brand strategy and the 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 translate insights into guidance for US stakeholders.
Serve as primary liaison with OPDP/APLB for assigned brands; manage FDA advisory review requests, address enforcement actions, and adjudicate incoming and outgoing 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 processes and guidelines; develop PRA guidance documents and job aids to improve clarity, speed, and quality of review and approval.
Monitor regulatory agency activities, guidance documents, and emerging trends, and share implications with PRA and cross-functional partners.
Contribute to PRA vision, practices, and operational plans, team objectives, measurable outcomes, 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.