Senior Manager, Advertising and Promotional Compliance, US
About The Position
The Senior Manager, Advertising and Promotional Compliance supports the US advertising and promotional compliance strategy for assigned products. The role ensures external communications are scientifically rigorous, fair-balanced, and aligned with FDA requirements, partnering with medical, legal, regulatory, commercial, and regulatory operations colleagues to guide promotional and scientific materials from concept through submission. The position provides regulatory guidance to cross-functional teams, supports timely product launches, and helps maintain consistent, ethical engagement across a growing portfolio. It also contributes to product development, labeling updates, review processes, regulatory submissions, and the communication of changing regulatory standards.
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 to ensure compliance with global standards and applicable FDA requirements for prescription drug advertising, promotion, and communication.
- Serve as the primary contact for OPDP and/or APLB communications for assigned products, including preparing and submitting promotional materials under FDA Form 2253 on time.
- Provide training support on prescription drug promotion requirements, including sales and compliance training and preparation for scientific conferences, as needed.
- Work with the manager to advise product development teams on advertising and promotion issues supporting the strategic development of new products.
- Ensure stakeholders are aware of proposed and newly approved labeling changes.
- Communicate planned label updates to PRC and MRC stakeholders, explain their impact on promotional and medical materials, and provide timely implementation guidance, including for ISI updates.
- Work with the manager and MLR Coordinator on processes and procedures for creating, reviewing, and approving advertising and promotional materials, and develop best practices for consistency across products.
- Maintain expertise in product promotion compliance by monitoring FDA enforcement actions and attending relevant conferences or seminars; communicate new regulatory standards to brand teams and management as appropriate.
- Analyze regulatory landscape changes with management and cross-functional partners, determine internal impacts, and communicate 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.
Benefits
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
