Associate Director, Advertising and Promotional Compliance, US

Associate Director, Advertising and Promotional Compliance, USThe Associate Director, Advertising and Promotional Compliance, US, will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications. The 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 material. The Director will also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials.AccountabilitiesReviewing US promotional, non-promotional, and scientific material, attending review meetings and providing regulatory guidance to the cross-functional team responsible for ensuring adherence to compliance standards and FDA regulations pertaining to prescription drug advertising, promotion, and communication as applicableServing as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) for assigned productsDeveloping processes and procedures relevant to the creation, review and approval of advertising and promotional materials: Developing best practices, working instructions and/or SOPs to establish standards and consistency across company brandsAs needed, providing training support within Alexion on requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific congresses and conferencesAdvising product development teams on advertising and promotion issues to facilitate the strategic development of new productsMaintaining regulatory expertise in product promotion and compliance by keeping current with issued FDA enforcement actions and through attendance of relevant conferences and/or seminars. Communicate new regulatory standards pertaining to prescription drug promotion to brand teams and management, as appropriateParticipating in and supporting ongoing key initiatives including the development, implementation, and continued improvement of promotional review processSupporting and mentoring ad/promo colleaguesEssential Skills/ExperienceBachelor’s degree3+ years pharmaceutical industry in regulatory affairs and/or advertising and promotionExpertise in US advertising and promotional regulations and the current regulatory environmentExperience communicating and negotiating directly with OPDP and/or APLBExperience leading a team or experience having direct reportsExperience with global standards for advertising and promotional complianceExcellent written and verbal skills and strong interpersonal skillsConsistent track record practicing sound judgment as it relates to risk assessmentKnowledgeable on industry compliance requirements and non-compliance examples and trendsDemonstrated ability to influence others and foster team collaborationStrong interpersonal, communication, and leadership skillsProficiency using Microsoft Office software and promotional review software, such as Veeva Promomats and Veeva MedcommsThe duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.Desirable Skills/ExperienceJD, PharmD or master’s degree preferredWe are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Date Posted12-Nov-2025Closing Date18-Nov-2025Our 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. #J-18808-Ljbffr