Associate Director, Regulatory, Advertising and Promotion

Position Summary: The Associate Director, Commercial Regulatory Affairs leads the review and approval of promotional and medical communications for assigned brands. The role involves interacting with regulatory bodies like the FDA, ensuring compliance with regulations, and guiding internal teams through promotional material development. This position requires collaboration with multiple departments, including legal and business ethics, to ensure products' promotional communications meet all required standards.

Key Responsibilities:

• Provide regulatory advice on FDA advertising and promotion issues for assigned products.
• Lead and manage the Promotional Review Committee (PRC) process and ensure materials meet regulatory standards.
• Develop and implement standard operating procedures (SOPs) to streamline processes.
• Liaise with regulatory agencies for product submissions and compliance.
• Collaborate with cross-functional teams to integrate regulatory guidance into business strategies.
• Manage tasks to support the compliant execution of marketing strategies and materials.

Qualifications:

• Minimum 6 years of experience in the pharmaceutical industry, with 4+ years in commercial regulatory affairs.
• Expertise in FDA regulations, promotional and medical review processes, and product labeling.
• Strong communication, negotiation, and leadership skills.

Core Competencies:

• Ability to interpret clinical trial data and understand promotional regulations.
• Excellent attention to detail and communication skills.
• Ability to influence cross-functional teams and lead multiple projects.