Rich Pelt

Senior Director, Global Regulatory Sciences, Vaccines CMC · Pfizer · company speakers →

Rich has over 25 years of CMC Regulatory Affairs with positions of increasing responsibility with GSK, PDL Biopharma, Wyeth Pharmaceuticals and currently with Pfizer, Inc as a senior director for vaccines CMC regulatory affairs. Rich currently leads a team of 30 CMC Regulatory professionals responsible for supporting the development and production of various vaccines for the prevention of Sars-CoV-2 (Covid 19), C. Difficile, RSV, Group B Streptococcus, and Influenza. Since the beginning of the pandemic, he has been one of the global leaders responsible for developing the BioNtech/Pfizer mRNA Covid-19 Vaccine. Rich has been responsible for CMC Regulatory leadership on various vaccine programs over the last 25 years including the Prevnar 13 Vaccine global market submissions and approvals, coral snake antivenin production restart as well as various development programs including Staphylococcus aureus and RSV. Rich has been an educator and guest speaker at various industry seminars and forums including The World Vaccine Congress, The American Association of Pharmaceutical Scientists National Biotechnology Conference, The International Society for Bioprocess Technology Nucleic Acids Conference, CASSS WCBP Conference, Academy for Institutional Investors Investment Forums, IBC Life Sciences programs, Regulatory Affairs Professional Society, and several other educational organizations. Rich is also the Author of CMC Regulatory Affairs 101: What does CMC Regulatory Affairs D o? (American Pharmaceutical Outsourcing: Nov./Dec. 2007), and a contributing reviewer for the 5 th edition of Fundamentals of US Regulatory Affairs (Chapter 15 on Biologics submission 2007) for the Regulatory Affairs Professionals Society. Rich received a Bachelor of Science degree in Chemical Engineering from NC State University. Rich is a 7-Time Ironman Triathlon finisher and was a division one swimmer for NC State University. When Rich is not working on vaccine development, he enjoys playing golf and spending quality time at the beach in Oak Island, NC with his family.

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