Harshil Desai
Regulatory Affairs Associate - International @Prestige Consumer Healthcare
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WORK HISTORY
Regulatory Affairs Associate - International @Prestige Consumer Healthcare
Tarrytown, NY, US
Delivered tailored regulatory submission and documentation support effectively managing new and existing registrations for OTC, Medical Devices, and Dietary Supplements across multiple international markets (Asia, Europe, Canada, Middle East and LATAM)- Managed regulatory lifecycle management for an Oral Rehydration Solution brand (6 products, 30+ SKUs) in Canada, aligning with Health Canada guidelines- Co-Authored a CTD dossier for an Ophthalmic product in Middle East, collaborating cross-functionally to synthesize technical, clinical, and quality data- Formatted 3 Oral Care product dossiers complying with LATAM regulatory templates, accelerating submission timelines by 15%- Secured 100% approval rate for 15+ USFDA export certificates (CFG, CPP), enabling product launches in 5+ global markets- Assisted in integration of 7+ new product registrations and recertification of 15+ existing products into WERCS system- Prepared and processed 20+ documents (legal, notarization and apostille) for international registrations, reducing renewal delays by 25%.
EDUCATION
Dwarkadas J. Sanghvi College of Engineering
Bachelor of Engineering - BE, Biomedical/Medical Engineering
Stevens Institute of Technology
Master of Science - MS, Biomedical/Medical Engineering
ABOUT HARSHIL DESAI
Regulatory Affairs Associate specializing in global product registrations for OTC drugs…
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