Senior Director, Regulatory Affairs – Advertising & Promotion

This is a fully remote position, open to applicants in United States.

📋 Description

• Assess Commercial, Legal/Compliance, and Medical viewpoints while offering expert regulatory advice on promotional, disease state education, corporate, and other non-promotional materials.

• Evaluate materials in Veeva and engage in Medical Review Committee and Promotional Review Committee meetings.

• Analyze and interpret enforcement actions as well as FDA Guidance to Industry documents.

• Contribute to the internal MRC/PRC processes to ensure materials align with FDA regulations.

• Provide insights on process improvements, compliance, and operational efficiencies.

• Formulate and execute a regulatory advertising and promotion strategy while managing complex negotiations.

• Direct communications with healthcare professionals, patients/consumers, payers, executive management, and other stakeholders.

• Oversee the submission of branded promotional materials to the FDA using Form 2253.

• Serve as the primary liaison with the FDA's Office of Prescription Drug Promotion.

• Counsel management and cross-functional teams on pertinent laws, regulations, guidelines, and standards.

• Ensure that corporate objectives are met for assigned projects.

• Represent Regulatory Affairs independently under the guidance of the Vice President of Regulatory Affairs.

• Potentially oversee direct reports and contribute to the performance management of other Regulatory Affairs team members.

• Participate in relevant professional associations, industry, and trade groups as appropriate.

• Adhere to budget allocations.

⛳️ Requirements

• Bachelor's degree in a scientific field and 12+ years of relevant experience, or a comparable combination of education and experience.

• An advanced degree (MS, PharmD) is preferred.

• In-depth knowledge of Regulatory Advertising and Promotion.

• Proven track record in preparing and submitting regulatory documents successfully.

• Strong grasp of Advertising and Promotion as well as regulatory requirements for prescription-drug promotion.

• Proficient user of the Veeva ecosystem for items related to the Promotional Review Committee.

• Excellent communication and proactive negotiation abilities.

• Capacity to communicate effectively and convey complex ideas clearly.

• Ability to thrive in a fast-paced, demanding, and collaborative environment.

• Willingness to travel up to approximately 5%.

🏝️ Benefits

• Bonus, stock options, benefits, and/or other applicable variable compensation may be part of the total compensation package.

• Travel up to approximately 5%.