Associate Director - Regulatory Affairs - Advertising & Promotion

Full-time - Senior

Plainsboro, NJ

Ambulatory Health Care Services

About the position

The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice on advertising and promotion for assigned products in accordance with business goals and objectives, FDA regulations and guidance's, and company policies.

Responsibilities

• Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape
• Assess risk and advise on mitigation strategies to meet overall business need, while maintaining compliance with US regulatory requirements and company operating procedures
• Maintain up-to-date knowledge of laws, regulations, and policies enforced by Federal and State governments as they relate to advertising and promotion of pharmaceuticals and devices
• Apply regulatory and therapeutic area knowledge to Brand Team's objectives and initiatives to develop solutions to promotional issues, while ensuring regulatory compliance and effectively managing business risks
• Creatively advise on the development of product messages and materials across multiple functional areas, and propose regulatory strategy and solutions to challenging promotional concepts that meet business objectives
• Provide training in FDA regulations for advertising and promotion to employees and agents of Novo Nordisk
• Collaborate with Regulatory Affairs colleagues to provide input to study designs or US labels regarding feasibility of promoting potential data/claims with manager oversight
• Participate/assist in US labeling negotiations as necessary. Ensure that changes in US Prescribing Information are reflected in current promotion and advertising in a timely manner
• Play a critical role in pre-launch and launch activities as necessary, including the development of launch materials/new claims by collaborating with Commercial, Medical and Legal
• Advise in the development and implementation of strategies to maintain efficient and compliant Promotional Review Board (PRB) process
• Serve as a primary regulatory advertising and promotion reviewer for assigned products
• Liaison with OPDP regarding advertising and promotion for assigned products. Oversees preparation and submission of draft introductory materials to OPDP for advisory comment
• Ensure company compliance with FDA requirements, including timely and accurate submission of advertising and promotional materials to OPDP with FDA Form 2253

Requirements

• A Bachelor's degree required; life science and advanced degree preferred
• A minimum of 7 years of experience in pharmaceutical/biologics industry or related field required, with 5 years of promotional review experience preferred
• Advanced knowledge of pertinent FDA regulations
• Broad hands-on related pharmaceutical experience and FDA regulatory experience; subpart H experience preferred
• Detail & deadline oriented; well-organized
• Excellent verbal & written communication skills
• Experience leading projects in specific regulatory area preferred
• Good interpersonal skills; ability to interact with staff on all levels
• Works independently with minimal supervision