Director, Regulatory Affairs (Advertising and Promotions)

Definium seeks an experienced promotional reviewer to join our Regulatory Affairs team. The Director, Regulatory Affairs (Advertising and Promotion) will have accountability for review and approval of US promotional materials and medical communications, and social media postings for assigned brand(s). This colleague will provide regulatory guidance related to promotional and advertising campaigns for marketed products and development programs. This role will also provide input into labeling strategies for marketed products and is responsible for leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB) pertinent to assigned brand(s). The individual will be responsible for the review of all submission types made to OPDP/APLB (FDA). The incumbent’s responsibilities include providing review of promotional and medical materials and functioning as a leader during the Medical, Legal, Regulatory (MLR) review process, providing clear guidance to ensure compliance with regulatory standards. This position requires frequent interaction and strong collaboration with Commercial, Medical Affairs, and Legal functions for the purpose of providing regulatory advice and guidance during promotional plan development from concept to field implementation, assuring conformity with FDA requirements, PhRMA DTC Guidelines, and Definium policies.

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 medical materials in Definium’s PromoMats system
• Represent the regulatory perspective in live MLR meetings and concept reviews
• Review and approval of social media posts
• Liaise with OPDP/APLB (FDA) as needed for assigned product(s) serving as our company's 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 complete, accurate, high-quality submissions for advisory comments, and as needed discussion with OPDP/APLB staff
• 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
• Aid in the development of processes and standards for promotional materials and related activities to facilitate streamlined workflows and encourage an efficient review process
• 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

Qualifications:

• Minimum BS in scientific discipline, advanced degree in science preferred
• Minimum 10 years’ experience in the pharmaceutical industry with at least 5 years as a regulatory advertising and promotional reviewer
• Experience in CNS is a plus
• Expert knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling
• Solid experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotional matters
• Experience in Veeva PromoMats a strong plus