Melissa Sayers

Melissa Sayers

Manager, Drug Team

Registrar Corp

About me

Melissa Sayers is the Manager of the Drug Team at Registrar Corp, where she leads teams supporting global pharmaceutical companies in navigating complex regulatory requirements across the United States and international markets. With over a decade of experience in pharmaceutical regulatory compliance, Melissa specializes in electronic submissions, including Structured Product Labeling (SPL) and electronic Common Technical Document (eCTD) formats. She has extensive experience supporting submissions to the U.S. Food and Drug Administration (FDA), Health Canada, and European regulatory agencies, helping organizations maintain compliance across multiple jurisdictions. Melissa’s expertise spans a wide range of regulatory programs and requirements, including drug establishment registration and listing, Generic Drug User Fee Amendments (GDUFA) and Over-the-Counter Monograph User Fee Program (OMUFA), CARES Act reporting, and compliance support for biologics, outsourcing facilities (503B), compounders, third-party logistics providers (3PLs), and wholesale distributors (WDD). Throughout her career, she has guided pharmaceutical companies through complex filings, product reporting obligations, and user fee requirements, with a focus on ensuring accuracy, efficiency, and regulatory alignment. She is also a recognized speaker and educator, regularly delivering industry webinars and training on evolving FDA regulations and compliance strategies. Melissa holds a Master of Science degree from Old Dominion University and has been with Registrar Corp since 2012, where she continues to support innovation and process improvement in regulatory submissions and client services.
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Networking Foundations

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is attending

Keynote: One Planet, One Purpose: Driving Change Through Sustainability Awareness

Tuesday, May 20, 2025 6:00 PM to 6:20 PM
Rachel Meidl · Baker Institute for Public Policy

Networking Break

Tuesday, June 2, 2026 2:35 PM to 2:55 PM
Main Stage

Inside the FDA: What’s Happening Now and What’s Coming Next?

Tuesday, June 2, 2026 3:00 PM to 3:20 PM
Main Stage

From Globalization to Geoeconomics: U.S. Pharmaceutical Manufacturing in a New Reality

Tuesday, June 2, 2026 1:15 PM to 1:45 PM
Main Stage

FDA in Flux: Navigating the New Regulatory Landscape

Tuesday, June 2, 2026 4:20 PM to 5:00 PM
Main Stage
Gil Roth · PBOA - Pharma & Biopharma Outsourcing Association

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