Senior Director, RA Advertising and Promotions

Role Summary

The Senior Director, Advertising and Promotion Regulatory Affairs will be responsible for developing and leading US regulatory strategies for promotion and advertising activities across assigned product portfolios, including new and existing assets in alignment with commercial brand plans and corporate compliance objectives. This role serves as a strategic regulatory partner to commercial, medical affairs and cross-functional stakeholders, enabling compliant, effective external communications while proactively identifying regulatory risks and mitigation strategies throughout the product lifecycle, including launch and post-marketing phases. Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.

Responsibilities

• Providing strategic leadership and oversight to Advertising & Promotion (Ad Promo) activities within the assigned therapeutic area on advertising and promotion regulatory issues, including early engagement on product launch strategies.
• Provide regulatory expertise as it relates to U.S. regulations for advertising and promotion of a prescription product on Commercial activities, including marketing strategies, marketing materials, training materials and digital engagement platforms.
• Provide regulatory expertise as it relates to U.S. regulations for advertising and promotion of a prescription product on Medical Affairs activities, including Medical strategies, materials and other information used with external customers by Medical Affairs personnel that could be impacted by these regulations.
• Act as the Regulatory Ad Promo subject matter expert for product launches and major campaign initiatives by identifying regulatory risks, developing mitigation strategies and enabling compliant execution.
• Identify areas for development of efficiencies for Advertising & Promotion process for the Promotional Review Process and Medical Review processes.
• Communicates/negotiates directly with the OPDP on advertising and promotional material on requests for advisory comments.
• Maintain effective partnerships with internal business stakeholders including, but not limited to Global Regulatory Leaders, Medical Affairs, Product Safety, Legal, Marketing, and Business Development to shape Ad Prom strategies.
• Review and provide regulatory guidance on promotional, educational and training materials intended for internal or external audiences that would be impacted by advertising and promotion regulations.
• Contributes to development of the prescribing information and provide feedback on updates to the product prescribing information.
• Provides training on advertising and promotion regulations to key stakeholders.
• Remains current on FDA regulations and guidance associated with advertising, promotion, and regulatory applications. Demonstrates role specific competencies and company values on a consistent basis.
• Perform other duties as assigned.

Qualifications

• Minimum of a Bachelor's degree (or equivalent) and relevant industry experience required.
• A degree in a scientific discipline is strongly preferred.
• An advanced degree (MS, PharmD, MD) in a scientific discipline is a plus.
• A minimum of 5 years of experience in Regulatory Affairs with subject matter expertise in Ad Promo. However, a combination of experience and/or education will be taken into consideration.
• Experience interacting directly with FDA OPDP is strongly preferred.
• Must possess expert knowledge of regulatory guidance pertaining to advertising, promotion for pharmaceutical products.
• Strong knowledge of regulatory environment and FDA.
• Excellent analytical, written and verbal communication, interpersonal, and project management skills.
• Strong work ethic and outstanding organization and time management skills.
• Strong computer skills and be proficient within the Microsoft Office Suite.
• Position functions autonomously. Responsibilities may include interviewing, hiring, and training employees; planning, addressing complaints and resolving problems.