Brijesh Parlekar
Director @Proregulatory Biosciences Ltd
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WORK HISTORY
Director @Proregulatory Biosciences Ltd
CA
Providing regulatory affairs support to biotechnology and pharmaceutical industryBiosimilar/Biologics/Cell therapy/ANDA
EDUCATION
South Gujarat University
Bachelor of Pharmacy, Pharmacy
Long Island University
MS, Pharmaceutical Sciences - Industrial Pharmacy
SKILLS
ABOUT BRIJESH PARLEKAR
Regulatory Affairs Skills: • Proven biosimilar regulatory affairs experience• Ability to drive biosimilar product from clone to commercialization• Ability to prepare and compile regulatory submissions for drugs (IND, NDA, ANDA), biologics (IND, BLA) and medical devices (IDE, 510K, PMA) in eCTD • Knowledge of Canada, EU, US and ROW regulatory requirement, submissions and approval pathways• Knowledge of the Code of Federal Regulations (CFR)• Undergone Regulatory Affairs Project Manager training at CDER, US FDA• Accurately interpret the regulatory guidelines and implement for the biosimilar development• Technology transfer to international companies
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