Janvi Rathod Email & Phone Number

Boston, Massachusetts, United States

• Played a key role in diverse regulatory submissions, including the successful IND submission for a novel gene therapy product, CMC amendment, and Pediatric Waiver, demonstrating a strong understanding of regulatory.
• Prepared and compiled a new IND: responsible for the preparation of Module 1, coordination of drafting and reviews of Module 3; review and formatting of Module 4 reports. Ensured appropriate formatting of regulatory.
• Major CMC amendment for facility and technology transfer: authored the Module 2 Quality Information Amendment document, coordinated drafting, reviews and finalization of Module 3, ensured the amendment was completed on.
• Worked on PRIME designation in Europe for a novel gene therapy product, highlighting strategic regulatory planning and collaboration with cross-functional teams.
• Conducted Regulatory Research focused on approvals, review documents and available treatments in the market for the specific therapeutic indications, ensuring a comprehensive understanding of the regulatory landscape.
• Conducted research on and submitted Pediatric Study Waiver Request, demonstrating skills in regulatory strategy and compliance with pediatric regulatory requirements.

Pune, Maharashtra, India

I have professional experience as a Pharmacy Intern at K Deccan Healthcare, where I worked on a multidisciplinary team to maintain regulatory standards for the storage and dispatch of life-saving drugs, generated temperature mapping reports from calibrated data loggers to monitor the storage conditions and temperature of oncology and ophthalmology.

Ms In Regulatory Affairs, Gpa- 4/4

Relevant Coursework: Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation, Regulatory Compliance and Practice.

Bachelor'S Degree, Pharmacy