Associate Director, Regulatory Affairs – Advertising and Promotion

Responsibilities

• Review and approval of all US promotional materials
• Serve as the promotional regulatory expert with legal, medical and commercial colleagues
• Ensure promotional practices are consistent with regulatory guidelines, company policies, and support business objectives
• Manage correspondence with FDA’s promotional review divisions OPDP/APLB
• Propose creative, effective, and compliant regulatory strategies and solutions
• Provide regulatory consultation in the development and implementation of US marketing strategy and promotional programs
• Support commercial teams by providing regulatory guidance on marketing strategies
• Participate in labeling and global regulatory team meetings
• Maintain current awareness of FDA advisory correspondence and regulations
• Provide promotional regulatory training and coaching to team members
• Contribute to departmental strategic initiatives

Requirements

• B.A. or B.S. degree with an emphasis in science, health care or related fields
• Minimum of five years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines
• Minimum of two years of direct experience as the primary regulatory reviewer of advertising and promotional materials
• Demonstrated knowledge of FDA regulations relating to advertising and promotion for prescription products
• Proactive with strong cross-functional collaboration skills
• Demonstrated history of successful interactions with the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch
• Understanding of the product development and labeling process
• Excellent verbal and written communication skills
• Attention to detail and ability to manage multiple priorities simultaneously
• Strong interpersonal skills with ability to demonstrate strategic and analytical thinking
• Demonstrated ability to negotiate and influence others effectively