TheAssociateDirector, Advertising and Promotion Compliance, USwill serve as the Regulatory Affairs(RA)representative forassigned products and therapeutic areas.They willbe responsibleforreviewing and approving the regulatory content of materials created for product promotion, diseaseawarenessand public affairs communications. TheAssociateDirector will also engage business partners for strategic planning on issuespertaining toproduct promotion and willparticipatein developing processes and procedures relevant to the creation,reviewand approval of promotional materials. TheAssociateDirectormayalso act as the primary liaison with FDA on ad/promo regulatory issues concerning promotionalmaterials.
Accountabilities:
ReviewingUS promotionaland non-promotional/scientificmaterial, attendingreviewmeetingsandprovidingregulatory guidance to the cross-functional team responsible for ensuringadherence toglobal compliance standards and FDA regulationspertaining toprescription drug advertising,promotion,and communicationas applicable
As needed, providingtraining support within Alexion on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences
Informing, reviewingand providingclear communication to all key stakeholders in both Promotional Review Committee (PRC) and Medical Review Committee (MRC) on planned label updates and how they may impact promotional and medical materials; provide key stakeholders with specific guidance on appropriate implementation of the label update, including ISI updates, for assigned therapeutic area in a timely manner
Participatesin developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials; develop best practices toestablishstandards and consistency across company products
Maintainsregulatoryexpertisein product promotion compliance by keeping current with issued FDA enforcement actions and through attendance at relevant conferences and/or seminars.Communicate new regulatory standardspertaining toprescription drug promotion to brand teams and management, as appropriate
Workswith management and cross-functional partners to analyze changes to the regulatory landscape anddetermineany internal impact and communicate and provide guidance to all impacted key stakeholders
Essential Skills/Experience:
Bachelor27s Degree
5 years of relevant experience and/or relevant PharmD post-doctoral Fellowship experience
Knowledge of U.S. advertising and promotional regulations
Experience communicating and negotiating directly with OPDP and/or APLB
Experience with global standards for advertising and promotion compliance
Knowledgeable on industry compliance requirements and non-compliance examples and trends
Experience with launching new products and/or new indication
Solid understanding of business goals and common marketing concepts/tools, including the internet and social media
Proficiency using promotional review software, such as Veeva Promomats and Veeva Medcomms
Desirable Skills/Experience:
Advanced degree
7 years of relevant experience and/or relevant PharmD post-doctoral Fellowship experience
History having direct reports or mentoring junior team members
Proven track record practicing sound judgment as it relates to risk assessment
Strong interpersonal, communication, and leadership skills
Proven ability to prioritize and meet critical business timelines
The annual base pay for this position ranges from $150,000 to $200,000 . Our positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
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Date Posted
17-Aug-2026
Closing Date
16-Sep-2026
