Prathmesh Deshpande
Regulatory Affairs Manager at Pfizer
Based in India
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Seniority
Manager
Department
Science
Location
India
Industry
Pharmaceutical Manufacturing
Company size
102K
Contact information
Reveal Prathmesh's email and phone
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p•••••••@••••••.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Prathmesh Deshpande
I am working with Pfizer Healthcare India Pvt Ltd as Manager CMC strategy Lifecycle management. Provide regulatory inputs in projects such as product transfer, alternate vendor qualification and all post approval changes at site. Coordinate across Site CFTs and global regulatory counterparts to get alignment on submission strategy and submission requirements. Author and review high quality CMC content for post approval changes. Ensure proper prioritisation of submissions for business critical projects. Involved in India Licensing activities like test license, mfg license applications, Competent technical staff applications and coordination with Central Beurau of Narcotics (CBN) for psychotropic substance applications. I have hands-on experience in the Quality Assurance department including document management, IPQA, batch release, Continuous Improvement. I am Six Sigma yellow belt certified by Pfizer.
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