The Review Committee Senior Specialist role is the lead for coordinating Regeneron’s promotional Review Committee (Medical, Legal, and Regulatory) activities and for ensuring the promotional review processes are conducted both in a highly compliant manner and in a timely and efficient manner. This role is responsible for tracking promotional materials from inception through approval, maintaining appropriate systems and documentation files, and coordinating any associated regulatory submissions.
This role is tasked with maintaining and enforcing associated operating procedures, managing high-quality committee meetings, ensuring continued compliance with all laws, policies and procedures, and providing guidance to promotional material sponsors on submission of high-quality and compliant work. This role will support more complex promotional material needs for brand stakeholders, will help with process change management, will lead projects, and will support management with the overall Review Committee Operations objectives.
A Typical Day May Include the Following:
Guide promotional material sponsors on review cycle timelines and assist with planning from submission for review through to approval.
Review promotional materials submitted for accuracy; verify and route submissions appropriately; provide proactive guidance on submissions where needed prior to Review Committee approval.
Serve as the facilitator for assigned Review Committee meetings ensuring that reviews are conducted according to all policies and procedures and that all outcomes are accurately recorded.
Ensure that all required revisions are incorporated in to all impacted materials in a timely manner.
Help to coordinate the submissions of materials to the FDA Office of Prescription Drug Promotion (“OPDP”) as required.
Facilitate planning and prioritization for FDA approvals and label updates for your assigned brands. Lead the launch Review Committee meetings.
Monitor performance and compliance metrics for your assigned brands. Advise on process and compliance improvement changes.
Advise on training and platform (e.g., PromoMats) improvements.
Facilitate partnership and shared accountability across the promotional review stakeholders including Reviewers, Sponsors, Commercial Operations, and Agencies.
This Role Might Be for You If:
Experience managing a Medical, Legal, Regulatory (MLR) review committee.
Strong customer service ethic with demonstrated ability to interact with management, customers, vendors and partners.
Experience working on a co-promote brand
Experience working across multiple therapeutic areas
Detail-orientated with strong problem-solving and conflict resolution skills.
Familiar with the drug development and commercialization process.
Proficiency with Adobe Acrobat Professional, Veeva PromoMats, Veeva Vault, MS Excel, MS Word, and MS Power Point
To be considered for this role you must have a Bachelor's Degree and 5-7 years of experience including related promotional review experience, preferably in advertising, medical education or pharmaceutical marketing. Certificate in Project Management a plus.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)