Director Of Regulatory Affairs Advertising And Promotion

Overview

• Lead regulatory affairs for advertising and promotional materials, ensuring compliance with FDA regulations and industry standards.
• Collaborate with cross-functional teams, including marketing, legal, and medical, to support brand initiatives.
• Provide strategic guidance and alternative solutions to achieve desired business outcomes.
• Serve as the primary contact for FDA's Office of Prescription Drug Promotion (OPDP) for assigned products.
• Develop and maintain procedures to ensure compliance with advertising and promotional regulations.
• Deliver training on FDA regulations for advertising and promotion to employees and agents.
• Contribute to health authority negotiations and regulatory submissions as needed.
• Stay updated on emerging trends and changes in FDA laws, regulations, and guidance.

Key Responsibilities & Duties

• Review product and disease state education materials for consistency with approved labeling and FDA regulations.
• Chair the Copy Clearance Committee and participate in multidisciplinary teams to ensure compliance.
• Establish and revise procedures to streamline review processes and minimize complexity.
• Build and maintain strong relationships with internal stakeholders to support promotional initiatives.
• Ensure timely and accurate submission of promotional materials to FDA under Form FDA-2253.
• Provide strategic support and guidance to business teams on regulatory challenges.
• Maintain knowledge of clinical trial design and interpretation to shape promotional strategies.
• Communicate complex regulatory issues clearly across all organizational levels.

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.
• High-level knowledge of FDA laws, regulations, guidance, and industry standards.
• Strong understanding of clinical trial design and data interpretation.
• Excellent communication skills, both written and verbal, for complex issue resolution.
• Ability to travel up to 20% as required.
• Proven ability to develop strategies based on emerging regulatory trends.
• Strong interpersonal skills to build relationships across departments.