Director Of Regulatory Affairs, Advertising & Promotion

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.