Associate Director, Promotional Regulatory Affairs

AstraZeneca • Wilmington, DE

6d • Hybrid

About The Position

The Associate Director, Promotional Regulatory Affairs provides regulatory guidance and risk assessment to cross-functional teams developing promotional initiatives intended to comply with U.S. laws, rules, and regulations governing pharmaceutical advertising and promotion. The role leads review and adjudication of promotional materials through the AstraZeneca Approval Process (AZAP), represents AstraZeneca before regulatory authorities for assigned brands and projects as appropriate, and advises partners on FDA promotional regulations and related guidance.

The position reviews promotional materials across healthcare professional, consumer, and managed-market audiences and across print, broadcast, and electronic media. Materials may include sales and faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and other items submitted through AZAP. The role also supports regulatory strategy, asset prioritization, brand implementation, training, FDA advisory review requests, product complaint adjudication, and monitoring and communication of regulatory developments.

The position is based on a hybrid working arrangement: employees work from the office an average minimum of three days per week, with flexibility around individual needs. The annual base pay range is $150,098 to $225,147. The role is eligible for incentives, including short-term incentive bonuses and equity-based awards for salaried roles. Benefits include qualified retirement programs, paid time off (including vacation, holidays, and leaves), and health, dental, and vision coverage, subject to applicable plan terms.

Requirements

• Bachelor’s degree in pharmacy, pharmacology, life science, or a related field, or equivalent experience; the posting describes this as a plus.
• At least 5 years of experience in drug or biologic regulatory affairs or a related pharmaceutical or biotechnology field.
• Working knowledge of FDA promotional regulations and the ability to apply that knowledge when reviewing diverse promotional materials and audiences.
• Working knowledge of the drug development process.
• Ability to manage a diverse workload and adjust quickly to changing business priorities.
• Ability to manage, coordinate, and execute projects independently with minimal supervision and in a timely manner.

Nice To Haves

• Experience with electronic review and approval programs such as VEEVA PromoMats or other systems.
• Experience influencing others’ decision-making.
• Experience in therapeutic areas of AstraZeneca focus.
• Pharmaceutical or biotechnology experience in regulatory, compliance, commercial, or medical affairs.
• 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 analytical thinking and decision-making skills.

Responsibilities

• Lead the review and adjudication of promotional materials as required through the AstraZeneca Approval Process (AZAP).
• Provide regulatory guidance and risk assessment for promotional initiatives intended to comply with applicable U.S. advertising and promotion laws, rules, and regulations.
• Represent AstraZeneca to regulatory authorities for assigned brands and projects, as appropriate.
• Provide promotional regulatory advice and support to cross-functional partners in line with their strategies and objectives, including current interpretations and recommendations concerning FDA promotional regulations and guidance.
• Review promotional materials for healthcare professional, consumer, and managed-market audiences across print, broadcast, and electronic media, as well as sales training, faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and other AZAP materials.
• Complete reviews within established timelines and accommodate expedited requests as priorities and workload allow.
• Assist in developing and implementing innovative regulatory strategies, including risk identification and contingency planning.
• Participate in asset prioritization and consultation meetings with Commercial Operations, MLR reviewers, and asset owners, as requested.
• Provide guidance to the business to support implementation of brand strategies, as requested.
• Develop promotional regulatory guidance and job aids for departmental and cross-functional use, as appropriate.
• Manage requests for FDA advisory review of materials and adjudicate incoming and outgoing competitor product complaints, as appropriate.
• Help evaluate brand regulatory training needs and develop and deliver training with the Internal and/or External Training Initiative or PRA Skill Center.
• Monitor regulatory agency activities, new guidance, and emerging regulatory trends, and share relevant information within PRA and the business.

Benefits

• Qualified retirement programs.
• Paid time off, including vacation, holidays, and leaves.
• Health coverage.
• Dental coverage.
• Vision coverage.
• Eligibility for short-term incentive bonuses.
• Eligibility for equity-based awards for salaried roles.

What This Job Offers

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