Senior Manager, Advertising and Promotional Compliance, US

AstraZeneca•Boston, MA

1d•$116,709 - $175,064•Hybrid

About The Position

This role supports the US advertising and promotional compliance strategy for assigned products. It ensures external communications are scientifically rigorous, fair-balanced, and aligned with FDA requirements. The position partners with medical, legal, regulatory, commercial, and regulatory operations colleagues to guide promotional and scientific materials from concept through submission, anticipate regulatory risks, and translate complex guidance into actionable direction. The work supports timely launches and ethical engagement across a growing portfolio. The role reviews US promotional and non-promotional/scientific materials, provides regulatory guidance, and serves as the primary contact with FDA’s OPDP and/or APLB for assigned products, including preparation and submission of promotional materials under FDA Form 2253. It also supports training, advises product development teams, communicates the impact of labeling changes, helps develop review processes and best practices, monitors regulatory developments, and participates in labeling negotiations and FDA meetings as needed.

Requirements

Bachelor’s degree.
Three years of relevant experience or relevant PharmD post-doctoral fellowship experience.
Solid knowledge of US advertising and promotional regulations.
Experience communicating and negotiating directly with OPDP.
Sound judgment in risk assessment.
Knowledge of industry compliance requirements and examples and trends in non-compliance.
Ability to influence others and foster team collaboration.
Strong interpersonal communication and leadership skills.
Ability to prioritize and meet critical business timelines.
Experience launching new products and/or new indications.
Ability to innovate, analyze, and solve problems with minimal supervisory input; anticipate and identify regulatory risks and make recommendations to management as appropriate.
Solid understanding of business goals and common marketing concepts and tools, including the internet and social media.

Nice To Haves

Advanced degree.
Experience with global standards for advertising and promotion compliance.

Responsibilities

Review US promotional and non-promotional/scientific materials, attend review meetings, and provide regulatory guidance on global compliance standards and applicable FDA regulations.
Serve as primary contact for communications with OPDP and/or APLB for assigned products, including timely preparation and submission of promotional materials under FDA Form 2253.
Provide training support on prescription drug promotion requirements, including sales training and compliance training for scientific conferences, as needed.
Advise product development teams on advertising and promotion issues in collaboration with the manager.
Ensure stakeholders are aware of proposed and newly approved labeling changes.
Communicate planned label updates and their potential impact on promotional and medical materials to stakeholders in PRC and MRC; provide timely guidance on implementation, including ISI updates.
Participate in developing processes, procedures, and best practices for creating, reviewing, and approving advertising and promotional materials, in collaboration with the manager and MLR Coordinator.
Maintain regulatory expertise by monitoring FDA enforcement actions and attending relevant conferences or seminars; communicate new promotional regulatory standards to brand teams and management as appropriate.
Analyze regulatory landscape changes with management and cross-functional partners, determine internal impacts, and provide guidance to affected stakeholders.
Collaborate with the advertising and promotion team and Regulatory Operations on creating and implementing novel submission processes.
Participate in or assist with US labeling negotiations and FDA meetings as necessary.