TheAssociateDirector, Advertising and Promotion Compliance, USwill serve as the Regulatory Affairs(RA)representative forassigned products and therapeutic areasThey 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
Servingas primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and/orAdvertising and Promotional Labeling Branch (APLB) for assigned products, including responsibilities for thetimelypreparation and submission of promotional materials under cover of FDA Form 2253
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
Providingadvice to product development teams on advertising and promotion issues tofacilitatethe strategic development of new products
Ensuringstakeholderawareness of proposed and newly approved labeling changes
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 seminarsCommunicate new regulatory standardspertaining toprescription drug promotion to brand teams and management, as appropriate
Works with management and cross-functional partners to analyze changes to the regulatory landscape and determineany internal impact and communicate and provide guidance to all impacted key stakeholders
Essential Skills/Experience:
Bachelor’s 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
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Joining Alexion means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and closer to each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the vibe, entrepreneurial spirit, and autonomy of a leading biotech. You’ll join an energizing culture where people build connections to explore new ideas. As an important member of our commercial team, you'll be meeting the needs of some of the most under-served patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient's journeys. You’re supported by exceptional leaders ready to lift you in marketing, compliance, and beyond.
The annual base pay for this position ranges from $150,000 to $200,000 . Our positions offer eligibility for various incentives—an 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.
Ready to make a difference? Apply now!
Date Posted
17-Aug-2026
Closing Date
16-Sep-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com.
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