Senior Director, Promotional Regulatory Affairs

AstraZenecaWilmington, DE
Hybrid

About The Position

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?

Requirements

  • 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.

Nice To Haves

  • Experience with VEEVA Promo Mats is preferred.
  • Therapeutic area expertise relevant to AstraZeneca.
  • Background in pharmaceutical promotional regulatory, compliance, or medical affairs.

Responsibilities

  • 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.
  • 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.
  • 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.
  • Advise senior leadership on complex promotional regulatory matters and exert substantial influence internally and externally to align on compliant, high-quality outcomes.
  • Drive process improvement and development of PRA guidance and job aids; contribute to PRA initiatives and develop departmental guidance that enables faster, better decisions.
  • Represent AstraZeneca as a subject matter expert in interactions with regulatory authorities and relevant external forums, strengthening credibility and shaping standards.

Benefits

  • We balance the expectation of being in the office while respecting individual flexibility.
  • A fast-moving, trusted environment where leaders remove barriers and empower teams to think big, start small, and scale fast.
  • Diverse perspectives brought together to tackle new challenges with digital and innovative solutions.
  • Kindness valued alongside ambition.
  • Support for growth as a strategic leader.
  • A commitment to lifelong learning, growth and development for all.
  • 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.
  • An environment where colleagues can wake up excited about their day at the office, in the field, or in the lab.
  • A promise to help colleagues realize the full breadth of their potential.
  • The opportunity to do work that has the potential to change your life and improve countless others.
  • The opportunity to shape a culture that unites and inspires every day.
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