Associate Director – Regulatory Affairs Advertising and Promotion

Associate Director – Regulatory Affairs Advertising and Promotion

Requirements

• PharmD/PhD 4+ years’ relevant experience.
• MA/MS/MBA with 8+ years’ relevant experience.
• BA/BS with 10+ years’ relevant experience.
• 4+ years’ experience in regulatory review of promotions for prescription drugs or other biologic products for external candidates.
• Significant experience leading development and execution of regulatory submissions of promotional materials for marketed prescription drug or biologic products.
• Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products.
• Experience chairing/leading promotional review committees or other relevant regulatory governance committees.
• Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus.
• Line management (direct reports) experience is a plus.
• Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities.
• Experience working with external contractors supporting the work of regulatory affairs is a plus.
• Experience authoring and/or implementing processes.
• Significant experience participating in cross-functional projects and teams.

Responsibilities

• Manages the commercial regulatory strategy and execution for one or more high-volume and/or otherwise complex brands or therapeutic areas.
• May manage, oversee, and review the work of one or more direct reports.
• Represents the commercial regulatory perspective at and chairs high-volume Promotional Review Committee (PRC) meetings for complex brands.
• May lead local cross-functional process improvements or other special projects.
• Provides strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands.
• May manage complex interactions related to promotional materials with regulatory agencies.
• Communicates relevant updates or changes to cross-functional leaders and teams.
• Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.
• Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.
• Serves as regulatory liaison to FDA/CDER/OPDP or FDA/CBER/APLB for assigned products, with managerial oversight, as appropriate.
• Represents RA Ad/Promo at Regulatory Project Team meetings.
• Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance.
• Mentors RA Ad/Promo and cross-functional team members as needed.
• Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.

Preferred Qualifications

• Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus.
• Line management (direct reports) experience is a plus.
• Experience working with external contractors supporting the work of regulatory affairs is a plus.