Associate Director, Promotional Regulatory Affairs

AstraZeneca GmbH; Gaithersburg (MD); On-site; USD 150,098 - 225,147; Full time

Benefits offered by this job

Incentives eligible

Health benefits

Retirement programs

Paid time off

Job summary

AstraZeneca in the United States is seeking an Associate Director Promotional Regulatory Affairs to provide regulatory guidance and risk assessment for promotional materials across HCP, Consumer, and Managed Markets audiences, ensuring compliance with FDA rules through the AZAP process.

You will lead reviews within timelines, collaborate with cross-functional teams, and develop PRA guidance and training while monitoring regulatory activity and evolving industry guidance.

Qualifications

• Bachelor’s degree in pharmacy, pharmacology, life science, or related field.
• 5 years’ experience in drug/biologic regulatory affairs or related pharmaceutical/biotech field
• Working knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences
• Working knowledge of the drug development process
• Experience with electronic review and approval programs (VEEVA PromoMats or other) a plus

Responsibilities

• Lead regulatory review and risk assessment of promotional materials through AZAP.
• Represent AstraZeneca to regulatory authorities for assigned brands and projects.
• Provide PRA guidance and job aids for cross-functional partners.
• Monitor regulatory agency activities and share insights within PRA and the business.

Skills

Regulatory affairs

FDA regulations

Cross-functional collaboration

VEEVA PromoMats

Education

Bachelor's degree in pharmacy

Tools

VEEVA PromoMats

Job description

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to help business teams develop and deliver initiatives that are intended to comply with applicable laws, rules and regulations governing the advertising and promotion of pharmaceutical products in the US. Lead review and adjudication of promotional materials as are required through the AstraZeneca Approval Process (AZAP). Represent AstraZeneca to regulatory authorities for assigned brand(s), and projects, as appropriate. Provide promotional regulatory advice and support to cross-functional partners in accordance with their respective strategies and objectives, as well as to provide current PRA interpretations and recommendations related to FDA promotional regulations and associated guidance.

Accountabilities

As the Associate Director Promotional Regulatory Affairs, you will ensure efficient and effective regulatory review and risk assessment of promotional material for all segments (HCP, Consumer, Managed Markets) and media (Print, broadcast and electronic), sales training, faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and any other materials required to be reviewed through AZAP. Conduct reviews within established timelines and meets expedited requests as priorities and workload allow. Assist in innovative regulatory strategy development and implementation, including risk identification and contingency planning.

You will participate with Commercial Operations, MLR reviewers, and asset owners in asset prioritization and consult meetings, as requested. Provide guidance to the business, as requested, to assist in implementation of Brand(s) strategy. Develop PRA guidance and job aids on relevant topics for use within the department and for use by cross-functional partners as appropriate

You will manage requests for FDA advisory review of materials and adjudication of incoming/outgoing competitor product complaints, as appropriate. Help to evaluate Brand(s) regulatory training needs, develop and deliver training in partnership with the Internal and/or External Training Initiative or PRA Skill Center. Monitor regulatory agency activities, new guidance, and emerging trends in the regulatory environment, and shares such information within PRA and the business, as appropriate.

Essential Skills / Experience

• Bachelors Degree in pharmacy, pharmacology, life science, or related field or equivalent experience a plus
• 5 years’ experience in drug/biologic regulatory affairs or related pharmaceutical/biotech field
• Working knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences
• Working knowledge of the drug development process
• Experience with electronic review and approval programs (VEEVA PromoMats or other) a plus

Desirable Requirements

• Experience influencing decision-making of others
• Experience in therapeutic areas of AZ focus
• Pharmaceutical or biotech regulatory/compliance/commercial/medical affairs experience
• Experience working in a team-based environment
• Collaborative and solution-oriented mindset
• Effective verbal and written communication and influencing skills
• Exemplary compliance ethics and high concern for standards
• Strategic and analytic thinking and decision-making skills
• Ability to manage a diverse workload and quickly adjust to changing business priorities
• Ability to manage, coordinate, and execute on projects independently with minimum supervision and in a timely manner

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 individualflexibility. Join us in our unique and ambitious world.

Why AstraZeneca? Here you will connect scientific rigor with commercial execution to make meaningful change for patients. We move with pace and purpose, bringing together diverse perspectives to spark ideas that translate into real-world impact. With autonomy to act and leaders who create a safe space to experiment and learn, you will help define how modern promotion and compliance come together—pairing cutting-edge channels with sound judgment. Your contribution will shape how we launch and scale medicines, improve the patient journey, and develop as a leader alongside colleagues who value kindness as much as ambition.

The annual base pay for this position ranges from $150,098 to $225,147.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.

Date Posted

23-Jul-2026

Closing Date

12-Aug-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.