Melinda Imperati

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Pfizer
Associate Director
Melinda Imperati is an Associate Director at Pfizer Global Regulatory Affairs Chemistry Manufacturing & Controls in Peapack, New Jersey. She has 26 years of experience, with increasing responsibility in the pharmaceutical industry, including extensive experience in technical and regulatory project management in support of innovative and established products. She is currently accountable to ensure appropriate regulatory resource, strategy, timely submission, and approvals for manufacturing site transfers as well as the legal entity name changes associated with the Viatris sale.

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An Evaluation of Postapproval CMC Change Timelines
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An Evaluation of Postapproval CMC Change Timelines

As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple countries simultaneously. As a result, Boards of Health (BoHs) are challenged with approving these applications in an accelerated timeframe and accommodating the submission of postapproval chemistry, manufacturing, and controls (CMC)...