Assoc Director, Regulatory Affairs – Advertising and Promotion

Role Overview

• responsible for the review and approval of all US promotional materials
• serving as the promotional regulatory expert with legal, medical and commercial colleagues
• serve as the liaison and manage correspondence with FDA’s promotional review divisions OPDP/APLB
• propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts
• provide regulatory consultation in the development and implementation of US marketing strategy and promotional programs
• support the US commercial teams by participating in strategy discussions and providing regulatory guidance
• provide promotional regulatory input on concepts and draft materials
• actively participate in labeling and global regulatory team meetings
• maintain current awareness and understanding of FDA advisory correspondence and regulations
• ability to take on more complex projects and provide promotional regulatory training and coaching to team members

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

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days