Rich Pelt
Senior Director, Vaccines CMC Regulatory Affairs at Pfizer | Cary, North Carolina, United States
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Rich Pelt serves as the Senior Director of Vaccines CMC Regulatory Affairs at Pfizer, where he leverages over three decades of extensive leadership experience in biopharmaceutical and pharmaceutical regulatory affairs. His role is pivotal in navigating the complex landscape of regulatory requirements for both development-stage and marketed conjugate vaccines and blood products. Since Pfizer's acquisition of Wyeth Pharmaceuticals in 2009, Rich has been instrumental in shaping the strategic direction of the company’s vaccine portfolio, particularly in the context of global health challenges.
Currently, Rich leads a talented team of CMC regulatory professionals focused on the development of innovative prophylactic vaccines, including those targeting Sars-CoV-2 and C. difficile. His expertise in international and multifunctional project management allows him to effectively coordinate with various health authorities, including the US FDA, EMA, and regulatory bodies in Canada, Japan, and Australia. Rich’s strategic planning and execution skills are critical in ensuring compliance with Good Manufacturing Practices (GMP) and facilitating smooth technology transfers.
In addition to his regulatory acumen, Rich excels in risk assessment and management, ensuring that potential challenges are identified and mitigated early in the development process. His comprehensive understanding of chemical engineering principles and validation processes further enhances his ability to guide complex vaccine development projects. By fostering collaboration across multidisciplinary teams, Rich not only drives regulatory success but also contributes to Pfizer's mission of delivering safe and effective vaccines to improve global health outcomes.
Senior Director, Vaccines CMC Regulatory Affairs at Pfizer in April 2005 to Present
Manager, CMC Regulatory Affairs at PDL BioPharma in January 2004 to April 2005
Sourcing Manager – Global Aerosols Sourcing Group at GSK in January 2001 to January 2003
Senior Regulatory Associate - CMC at GSK in January 1997 to January 2001
Staff Chemical Engineer at Radian International in January 1989 to January 1997
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North Carolina State University, Bachelor of Science (BS), January 1985 to January 1989
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CMC Regulatory Affairs
Project Management
Chemical Engineering
Vaccines
Pharmaceutics
Biopharmaceuticals
FDA
Regulatory Submissions
IND
Regulatory Affairs
Biotechnology
CMC
Change Control
Validation
21 CFR Part 11
CAPA
V&V
GMP
Technology Transfer
Pharmaceutical Industry
SOP
U.S. Food and Drug Administration (FDA)
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Discover more about PfizerWhat is Rich Pelt email address?
Email Rich Pelt at [email protected] and [email protected]. This email is the most updated Rich Pelt's email found in 2026.
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To contact Rich Pelt send an email to [email protected] or [email protected].
What company does Rich Pelt work for?
Rich Pelt works for Pfizer
What is Rich Pelt's role at Pfizer?
Rich Pelt is Senior Director, Vaccines CMC Regulatory Affairs
What is Rich Pelt's Phone Number?
Rich Pelt's phone (704) ***-*351
What industry does Rich Pelt work in?
Rich Pelt works in the Pharmaceuticals industry.
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