Associate Director, Promotional Regulatory Affairs

About the role

The Associate Director Promotional Regulatory Affairs will work with a cross-functional review team to provide regulatory guidance and risk assessment for promotional materials and initiatives.

Responsibilities

• Lead review and adjudication of promotional materials as required through the AstraZeneca Approval Process (AZAP).
• Represent AstraZeneca to regulatory authorities for assigned brands and projects, as appropriate.
• Provide promotional regulatory advice and support to cross-functional partners in alignment with their strategies and objectives.
• Conduct reviews within established timelines and meet expedited requests as priorities and workload allow.
• Assist in innovative regulatory strategy development and implementation, including risk identification and contingency planning.
• Participate in Commercial Operations, MLR reviewers, and asset owners in asset prioritization and consult meetings, as requested.
• Develop PRA guidance and job aids on relevant topics for use within the department and for use by cross-functional partners as appropriate.
• Manage requests for FDA advisory review of materials and adjudication of incoming/outgoing competitor product complaints, as appropriate.
• 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 share such information within PRA and the business, as appropriate.

Requirements

• Bachelor’s degree in pharmacy, pharmacology, life science, or related field or equivalent experience.
• 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.
• Experience with electronic review and approval programs (VEEVA PromoMats or other) is 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.