Associate Director, Promotional Regulatory Affairs

AstraZeneca • Gaithersburg, MD

8d • Hybrid

About The Position

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.

Requirements

• 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

Nice To Haves

• Experience with electronic review and approval programs (VEEVA PromoMats or other) a plus
• 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

Responsibilities

• 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.
• 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.
• 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.

Benefits

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage
• eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.

What This Job Offers

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