Associate Director, Regulatory Affairs Advertising and Promotion

Role Summary

As the Associate Director, Regulatory Affairs Advertising & Promotion you will provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/ guidances, PhRMA guidelines, and company policy.

This position will be located at the East Hanover site and will not have the ability to be located remotely. This position will require 20% travel as defined by the business (domestic and/ or international).

Please note that this role would not provide relocation, and only local candidates will be considered.

Responsibilities

• Serves as a primary regulatory advertising and promotion reviewer for assigned products on Materials Approval Process (“MAP”) teams. May include a launch product or indication with manager oversight.
• Liaison with OPDP regarding advertising and promotion for assigned products, including products approved under Subpart H with manager oversight. Establishes strong and positive working relationship with OPDP reviewers. Manages OPDP queries on assigned products.
• Applies regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to US promotional issues.
• Ensures regulatory compliance while effectively managing business risks.
• Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.
• Prepares complaint letters to OPDP with manager oversight.
• Conduct reviews of materials to be used by medical personnel in discussions with customers.
• Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings.
• Collaborates with Regulatory Affairs colleagues to provide input to study designs or US label regarding feasibility of promoting potential data/claims with manager oversight.
• Participates/assists in US labeling negotiations and FDA meetings as necessary.
• Ensures that changes in US Prescribing Information are reflected in current promotion and advertising.

Qualifications

• BS Degree or equivalent. Advanced degree desirable (MS, PhD, PharmD, or JD)
• Minimum 2 years regulatory experience or related medical information and/or promotional review experience.
• Knowledge and understanding of US regulations for drug promotion/advertising and US labeling
• Understanding of business goals of the involved business franchise, marketing concepts and tools
• Must be able to work in a multi-disciplinary environment
• Must process strong interpersonal and communication skills
• Must have analytical and problem-solving skills associated with problem review and inquiries.
• Must be able to provide creative solutions to problems

Desirable

• Ability to analyze and interpret efficacy and safety data desired