Senior Review Committee Specialist

Role Summary

Lead and coordinate promotional review activities within Regeneron's Commercial Operations team. Ensure compliance, efficiency, and excellence in review processes across multiple therapeutic areas. This hybrid role requires onsite work four days per week.

Responsibilities

• Guide promotional material sponsors through review cycle timelines, from submission to approval.
• Review promotional materials for accuracy, ensuring compliance and routing submissions appropriately.
• Facilitate and lead Review Committee meetings to maintain adherence to policies and procedures.
• Coordinate submissions of promotional materials to the FDA Office of Prescription Drug Promotion (OPDP) as required.
• Oversee planning and prioritization for FDA approvals and label updates for assigned brands.
• Monitor performance and compliance metrics, advising on process improvements.
• Support training initiatives and recommend enhancements to platforms like PromoMats.
• Foster partnerships and shared accountability across stakeholders, including reviewers, sponsors, and agencies.

Qualifications

• This role may be for you if you have a strong customer service ethic and excel in building relationships with management, customers, vendors, and partners.
• You thrive in a detail-oriented role and are skilled in problem-solving and conflict resolution.
• You are familiar with the drug development and commercialization process and have experience working across multiple therapeutic areas.
• You enjoy managing high-quality committee meetings and ensuring compliance with all laws, policies, and procedures.
• Bachelor’s Degree.
• 5–7 years of related promotional review experience, preferably in advertising, medical education, or the pharmaceutical industry.
• Experience managing Medical, Legal, and Regulatory (MLR) review committees is essential, as is experience with co-promote brands.
• A certificate in Project Management is a plus.