Associate Director, Regulatory Affairs Advertising and Promotion

This role is responsible for supporting regulatory review and activities related to advertising/promotion of marketed pharmaceutical products in oncology, endocrinology, and hematology. The position requires an understanding of regulatory frameworks, strategic thinking, and the ability to navigate complex regulatory compliance requirements.

Requirements

• Direct regulatory review of US/Canadian commercial product and disease state materials/communications
• Ensures promotional materials meet ad/promo regulatory and company requirements
• Ensures timely review of materials to meet internal timelines, requirements, and compliance with approved product labels
• Submits product promotional material to OPDP (Office of Prescription and Drug Promotion) on Form FDA 2253 in a timely manner as per regulations
• Coordinates cross-functionally and drives to resolution issues that impact promotional activities
• Provides insights and guidance to multiple functional areas on the development of product messages, assets, programs, tactics, etc.
• Reviews concepts, materials, and communications used in scientific exchanges; represents Regulatory Affairs on the Medical Review Committee (MRC)
• Maintains up-to-date knowledge of laws, regulations, and policies enforced by FDA as they relate to advertising/promotion of pharmaceuticals products
• Handles additional duties and special projects, as assigned by the Director of RA Ad/Promo
• Continually assesses ad/promo-related processes to enhance efficiency and compliance
• Monitors competitor advertising to keep abreast of market promotional and advertising strategies
• Monitors OPDP enforcement actions and assesses potential learnings/impact

Benefits

• Health Insurance
• Retirement Benefits: 401k
• Paid Time Off: Vacation, holiday, and sick/personal time