Director of Regulatory Affairs, Advertising & Promotion Overview • The Director of Regulatory Affairs, Advertising & Promotion oversees regulatory compliance for promotional materials and external communications. • Collaborates with cross-functional teams to ensure adherence to FDA regulations and industry standards. • Provides strategic advice on communication strategies for assigned products and disease areas. • Maintains current knowledge of FDA laws, regulations, and guidance related to advertising and promotion. • Develops and implements procedures to ensure compliance with regulatory requirements. • Serves as a primary contact for FDA’s Office of Prescription Drug Promotion (OPDP). • Provides training to employees and agents on FDA advertising and promotion regulations. • Supports health authority negotiations and contributes to regulatory submissions. • Leads efforts to streamline review processes and enhance compliance efficiency. Director of Regulatory Affairs, Advertising & Promotion Key Responsibilities & Duties • Review and provide oversight for product and disease state education materials. • Ensure promotional materials align with approved labeling and FDA regulations. • Chair the Copy Clearance Committee and participate in global regulatory teams. • Advise departments on compliance requirements for advertising and promotion. • Establish and revise procedures to ensure regulatory compliance. • Provide training on FDA regulations for advertising and promotion. • Develop strategies based on emerging trends in regulatory compliance. • Build and maintain strong relationships with internal stakeholders. • Coordinate timely and accurate submission of promotional materials to FDA. Director of Regulatory Affairs, Advertising & Promotion Job Requirements • Bachelor’s degree in a health or science-related field; advanced degree preferred. • Minimum of 10 years of experience in regulatory advertising and promotion review. • In-depth knowledge of FDA laws, regulations, and industry standards. • Strong interpersonal and communication skills, both written and verbal. • Ability to communicate complex issues clearly and concisely. • Experience with clinical trial design and interpretation of clinical data. • Proven ability to shape strategies based on emerging trends. • Willingness to travel up to 20% as required. • Demonstrated ability to lead cross-functional teams effectively.