Posted 1 day ago
Associate Director, Advertising and Promotional Compliance, US
Job description
The Associate Director, Advertising and Promotion Compliance, US will serve as the Regulatory Affairs (RA) representative for assigned products and therapeutic areas. They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications. The Associate Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional materials. The Associate Director may also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials. Accountabilities: Reviewing US promotional and non-promotional/scientific material, attending review meetings and providing regulatory guidance to the cross-functional team responsible for ensuring adherence to global compliance standards and FDA regulations pertaining to prescription drug advertising, promotion, and communication as applicable Serving as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) for assigned products, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253 As needed, providing training 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 Providing advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products Ensuring stakeholder awareness of proposed and newly approved labeling changes Informing, reviewing and providing clear 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 Participates in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials; develop best practices to establish standards and consistency across company products Maintains regulatory expertise in product promotion compliance by keeping current with issued FDA enforcement actions and through attendance at relevant conferences and/or seminars. Communicate new regulatory standards pertaining to prescription drug promotion to brand teams and management, as appropriate Works with management and cross-functional partners to analyze changes to the regulatory landscape and determine any 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.
Skills and functions
- Marketing