Jay Desai Email & Phone Number

Toronto, Ontario, Canada

• Project - NDS SubmissionPerformed tasks over 3 months of supervised internship:
• Successfully prepared various submission documents and used the CTD backbone to meet Health Canada's validation criteria for the preparation of CTD submissions, ensuring full compliance with the Canadian and.
• Interpreted and applied ICH-M4, and Health Canada's regulations, guidance documents, and policies, and used them to effectively prepare, compile, and format regulatory documents in accordance with regulatory guidelines.
• Demonstrated a comprehensive understanding of CTD requirements for Health Canada, enabling the development of a Regulatory Strategy for optimally preparing NDS in CTD format for submission to Health Canada.
• Collaborated effectively within the team to coordinate the compilation of necessary documentation, ensuring seamless information exchange and timely completion of regulatory submissions.
• Proactively acquired and applied Regulatory Project Management skills, including the utilization of tools such as Gantt charts, to ensure efficient planning and execution of submissions in CTD format, resulting in.

Collaborated extensively with the Regulatory Affairs team and engaged in cross-functional meetings to ensure seamless regulatory submissions, fostering effective communication among local and global stakeholders such as Product Development Regulatory, Pharma Technical Regulatory, and GxP.Formulated a robust regulatory strategy document to guide the.

Ms In Regulatory Affairs

Msc., Medical Biotechnology