Director, Promotional Regulatory Affairs

AstraZeneca • Wilmington, DE

1d

About The Position

AstraZeneca Wilmington is seeking a Promotional Regulatory Affairs Director to join its Promotional Regulatory Affairs team. This strategic, high-impact role provides regulatory guidance across assigned brands and business areas. The Director works independently with cross-functional teams to assess risk, advise strategically, and lead the review of promotional materials through the Medical, Legal, Regulatory (MLR) Approval Process.

The role also involves developing regulatory strategies, advising business leaders and global teams on U.S. promotional activities, serving as a liaison with OPDP/APLB, supporting regulatory training, monitoring regulatory trends, and mentoring less experienced staff. The position requires strong expertise in FDA promotional regulations and a commitment to regulatory compliance.

Requirements

• Bachelor's degree in Science.
• At least 3 years of experience in promotional regulatory affairs.
• Experience with FDA advertising and promotion review.
• At least 5 years of experience in the pharmaceutical or biotech industry.
• High ethical standards and commitment to regulatory compliance.
• Teamwork and effective communication skills, including the ability to influence diverse stakeholders.
• Strategic thinking and sound decision-making under pressure.
• Prioritization and project management skills in dynamic environments with tight deadlines.
• Attention to detail combined with a holistic business perspective.

Nice To Haves

• Advanced degree such as a PharmD, MS, PhD, or JD.
• At least 5 years of specific experience in promotional regulatory affairs.
• Proven experience influencing strategic decisions and mentoring teams.
• Direct interaction with OPDP or an FDA review division.
• Experience with products in Oncology, Respiratory/Immunology, or Cardiovascular/Renal/Metabolic therapeutic areas.
• Familiarity with electronic review and approval platforms such as VEEVA PromoMats.

Responsibilities

• Review and assess the risk of promotional materials across segments and media, prioritizing deliverables to meet deadlines, including urgent requests.
• Develop and implement regulatory strategies for assigned brands, identifying risks and planning contingencies.
• Collaborate with stakeholders on asset prioritization and participate in consult meetings.
• Advise business leaders on brand strategy and provide global teams with input on the impact of U.S. promotional activities.
• Develop departmental guidance documents and supporting materials, including job aids.
• Serve as liaison with OPDP/APLB and manage FDA advisory reviews, enforcement actions, and competitor complaints.
• Assess and deliver regulatory training, monitor emerging regulatory trends, and share key insights.
• Build strong relationships across the business to improve outcomes and support informed decision-making.
• Mentor and support less experienced staff and serve as a subject matter expert.

Benefits

• Collaborative environment.
• Continuous professional development opportunities.
• Opportunity to work alongside industry colleagues.

What This Job Offers

• Job Type: Full-time
• Career Level: Director