Associate Director, Global Regulatory Affairs - Ad/Promo

Responsibilities

• Lead the review and approval of US promotional materials and medical communications for assigned brands
• Serve as the internal subject matter expert on FDA Advertising & Promotion matters
• Manage regulatory interactions with the FDA, specifically the Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB)
• Ensure timely and accurate FDA 2253 submissions of US promotional materials
• Provide regulatory advice and guidance to Commercial, Medical Affairs, Legal, and Global Regulatory Affairs teams
• Develop processes and standards to facilitate streamlined promotional material workflows
• Provide regulatory training on FDA requirements and PhRMA DTC Guidelines

Requirements

• BS in a scientific discipline
• Minimum of 8 years of experience in the pharmaceutical industry
• Minimum of 5 years of experience in regulatory affairs
• Expert knowledge of FDA advertising and promotion regulations and guidance documents
• Proven experience working with OPDP and APLB on advertising and promotion matters
• Experience overseeing and authoring OPDP submissions

Preferred Qualifications

• Experience in Oncology is a plus

Benefits

• Competitive remuneration packages
• Annual bonus and equity opportunities
• Comprehensive wellbeing support and diverse employee benefits

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We focus on addressing diseases with high medical needs, such as cancer and various infectious diseases, through innovative mRNA-based solutions.