Director Of Regulatory Affairs Advertising And Promotion

Overview

• Drive regulatory affairs for advertising and promotional materials, ensuring adherence to FDA regulations and industry standards.
• Collaborate with marketing, legal, and medical teams to support brand initiatives and compliance.
• Provide strategic guidance to optimize promotional strategies while meeting regulatory requirements.
• Act as the primary liaison with FDA's Office of Prescription Drug Promotion (OPDP) for assigned products.
• Develop and implement procedures to ensure compliance with advertising and promotional regulations.
• Deliver training programs on FDA regulations for advertising and promotion to internal teams.
• Contribute to regulatory submissions and health authority negotiations as needed.
• Stay informed on emerging trends and updates in FDA laws, regulations, and industry practices.

Key Responsibilities & Duties

• Review promotional materials for compliance with approved labeling and FDA regulations.
• Lead the Copy Clearance Committee and collaborate with multidisciplinary teams to ensure compliance.
• Streamline review processes by establishing and revising procedures to enhance efficiency.
• Build and maintain 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 to business teams on navigating regulatory challenges effectively.
• Maintain expertise in clinical trial design and data interpretation to shape promotional strategies.
• Communicate complex regulatory issues clearly across all organizational levels to ensure understanding.

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.
• Comprehensive knowledge of FDA laws, regulations, guidance, and industry standards.
• Strong understanding of clinical trial design and data interpretation.
• Exceptional communication skills, both written and verbal, for resolving complex issues.
• Ability to travel up to 20% as required for business needs.
• Proven ability to develop strategies based on emerging regulatory trends and updates.
• Strong interpersonal skills to foster collaboration across departments and teams.