Harshil Desai Email & Phone Number

Jersey City, Nj, Us

Tarrytown, New York, United States

- Fostered authoring CTD for UAE by facilitating cross-functional collaboration with diverse teams- Delivered tailored administrative regulatory support to effectively manage and uphold the registration status of OTC drugs, medical devices, and dietary supplements in diverse international markets- Assisted in integration of new product registrations and recertification of existing products into WERCS system

San Jose, California, United States

- Reviewed clinical trial research protocol documents of Ph. 3 NASH trials for compliance with ICH GCP, FDA and NDCTR 19 regulatory guidelines- Monitored SUGAM portal daily to check for regulatory compliance and document submission tracking and queries- Provided administrative support to CRA adhering to SOP’s, customizing, and maintaining clinical trial documents like study protocol documents, country specific ICF’s, CRF’s, SIV reports, follow-up letters, protocol assessments - Contributed to tailoring CDAs and audit invoice sheets in accordance to updates through regular cross- functional communications, tracking and negotiating with 20 P.I.s

India

- Communicated and contributed with team members to complete administrative tasks in a given timeframe- Integrated into optimizing records and managing product information- Supported in quality check of over 100 hip prosthesis products, ensuring compliance with safety standards

Valsad, Gujarat, India

- Identified vital data to modernize company database accessibility increasing efficiency by 25%- Created and listed the company on various digital marketing platforms improving productivity by 15%- Coordinated a new project for the export of goods to West Africa generating $50K in new revenue- Supervised logistics including inventory management and delivery scheduling

Mumbai, Maharashtra, India

Organised and managed various sports events.

Mumbai, Maharashtra, India

Responsible for organizing and supervising events related to the biomedical field.

Master Of Science - Ms, Biomedical/Medical Engineering, 3.7 / 4

Bachelor Of Engineering - Be, Biomedical/Medical Engineering, 2.5

Activities and Societies: Cultural Head - PACEMAKERS Sports Head- TRINITY Security Head- TRINITY