Senior Review Committee Specialist

Regeneron Pharmaceuticals • Sleepy Hollow, WY

3d • Hybrid

About The Position

At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. Join our dynamic Commercial Operations team as a Senior Specialist, Review Committee. In this pivotal role, you will lead and coordinate promotional review activities, ensuring compliance, efficiency, and excellence in all processes. This is your chance to create a significant impact by contributing to the success of multiple therapeutic areas while working in a collaborative and innovative environment. This is a hybrid role, onsite requirement is 4 days per week.

Requirements

• To qualify, you must hold a Bachelor’s Degree and have 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.

Nice To Haves

• A certificate in Project Management is a plus.

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.

Benefits

• We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level