Global GxP Regulatory Intelligence Compendia Manager (Contract)00000
About This Gig
Job Description The Global GxP Regulatory Intelligence Compendia Manager will be responsible for the ongoing monitoring and management of compendial updates for clinical and commercial programs and ensuring compliance with global pharmacopoeia standards and regulatory submissions. This role will focus on maintaining alignment with the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and assist in expanding the program to include additional international pharmacopeia such as the Mexican Pharmacopoeia (Mexico Ph), Chinese Pharmacopoeia (ChP), and Japanese Pharmacopoeia (JP) and others Key Duties & Responsibilities Compendial Monitoring and Analysis: Continuously monitor updates and revisions to EP, USP, Mexico Ph, ChP, and JP and others as programs expand. Analyze changes in compendial requirements, work with SMEs to assess impact on company products, processes, regulatory submissions and documentation. Stakeholder Communication and Updates: Attend relevant forums, con
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About the Seller
Vertex Pharmaceuticals
on Himalayas