Senior Director, Promotional Regulatory Affairs
AstraZeneca
Overview Are you ready to set the promotional regulatory strategy for a high-impact portfolio and guide how our science reaches patients and healthcare professionals responsibly? In this role, you will translate complex FDA standards into clear, decisive direction that enables our brands to move at pace—without compromising on ethics or patient trust. You will lead a team that partners closely with senior leaders and cross‑functional colleagues, ensuring our promotional materials are not only compliant, but also precise, timely, and purposeful. By fusing scientific depth with commercial acumen, you will help operationalize our pipeline today and shape the standards for tomorrow’s launches. Can you anticipate regulatory risk, turn it into practical guidance, and elevate decision‑making across the enterprise? Accountabilities Team Leadership and Development: Manage, develop and lead a team responsible for provision of strategic advice and review of promotional materials across a therapeutic area, ensuring staff development and adherence to established processes. Promotional Regulatory Strategy: Set promotional regulatory strategy and priority for the therapeutic area; advise senior leadership on the promotional regulatory impact of business strategy development; provide input to global teams on US promotional impact. Material Review Excellence: Oversee efficient regulatory review of promotional materials across all segments and media through the MLR process; liaise with Commercial Operations on MLR governance to drive consistency and speed. Senior Counsel and Influence: Advise senior leadership on complex promotional regulatory matters and exert substantial influence internally and externally to align on compliant, high‑quality outcomes. Process and Guidance Improvement: Drive process improvement and development of PRA guidance and job aids; contribute to PRA initiatives and develop departmental guidance that enables faster, better decisions. External Representation: Represent AstraZeneca as a subject‑matter expert in interactions with regulatory authorities and relevant external forums, strengthening credibility and shaping standards. Essential Skills/Experience Requires a degree in pharmacy, pharmacology, science, or related field (or equivalent experience). Needs 7+ years in promotional regulatory affairs or FDA advertising/promotion review. Requires 10+ years in drug/biologic regulatory affairs or a related pharmaceutical/biotech field. Experience successfully leading teams, directly or indirectly, and influencing and mentoring others. Expert knowledge and application of FDA promotional regulations. Ability to successfully engage senior leaders/executive presence. Knowledge of drug development process and team collaboration. Strong communication, influencing, and analytic skills. High ethical standards and compliance. Ability to manage projects and workloads independently. Desirable Skills/Experience Experience with VEEVA Promo Mats is preferred. Therapeutic area expertise relevant to AstraZeneca. Background in pharmaceutical promotional regulatory, compliance, or medical affairs. Working Environment We expect members of the team to be in the office a minimum of three days per week, while respecting individual flexibility. The role may involve in‑person collaboration and occasional travel as needed. Equal Opportunity 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. #J-18808-Ljbffr
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