Associate Director, Global Regulatory Affairs

Role Summary

The Associate Director, Regulatory Affairs (Advertising and Promotion) will have accountability for review and approval of US promotional materials and medical communications of assigned brand(s). This role provides input and executes regulatory compliance/strategy related to promotional and advertising campaigns for marketed products and development projects, and leads interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB) pertinent to assigned brand(s).

Responsibilities

• Serve as the internal subject matter expert on FDA Advertising & Promotion matters for assigned product(s), providing regulatory advice and offering solutions to reconcile regulatory comments on draft promotional materials to maintain compliance with FDA regulations.
• Review and approval of promotional and advertising materials in BioNTech‚Äôs content management applications and systems.
• Ensure timely and accurate FDA 2253 submissions of US promotional materials.
• Ensure that changes and updates in prescribing information are reflected in current promotional and advertising materials.
• Liaise with OPDP/APLB (FDA) as needed for assigned product(s), serving as the single point of contact with FDA on matters related to advertising and promotional materials; manage interactions with OPDP/APLB, including response to regulatory inquiries, preparation of submissions for advisory comments, and discussions with OPDP/APLB staff as needed.
• Develop processes and standards for promotional materials and related activities to facilitate streamlined workflows and proficient practice of process policy.
• Provide regulatory training as needed on FDA requirements, PhRMA DTC Guidelines and Company policy with respect to best practices in compliance with company policies and guidelines for PRC processes.
• Demonstrate leadership as the regulatory reviewer on copy approval teams such that recommendations are well-reasoned, valid and appropriate.

Qualifications

• Education: Minimum BS in scientific discipline.
• Experience: Minimum of 8 years experience in the pharmaceutical industry and a minimum of 5 years in regulatory affairs; experience in Oncology is a plus; expert knowledge of advertising promotion regulations and FDA Guidance documents; some technical experience in drug development and labeling; solid experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotion matters; oversight of OPDP submissions and authoring submissions for assigned products.