Kishorekumar Subramanian

● Crafted detailed regulatory frameworks for a drug-device combination product leveraging advanced AI technologies; in compliance with CMDR, ISO 14971, and ISO 13485 while meeting critical market entry deadline

● Instituted an efficient workflow for compiling complex regulatory documents such as CTAs & ITAs by streamlining data collection methods—resulting in a 40% decrease in submission preparation time within three months.

● Directed comprehensive reviews of all documentation related to the pre-clinical and clinical requirements, and MDEL applications, identifying critical areas for improvement which led to enhanced submission accuracy rates of at least 30%.

· Independently managed end-to-end publishing and submission processes for Health Canada, FDA, and WHO filings, ensuring regulatory compliance and on-time delivery.

· Compiled and submitted post-market variations (e.g., FDA PAS/CBE, HC SANDS/Level III, WHO Variations) with 100% compliance during internal audits.

· Conducted regulatory change control assessments, improving submission readiness and adherence to Canadian regulatory requirements.

· Supported and prepared pre-submission materials and participated in FDA and WHO meetings under RA leadership guidance.

· Led operational aspects of electronic document management systems (VEEVA, educe and Lorenza docubridge), including archiving, testing, and user training.

· Reviewed and authored regulatory documentssuch as specifications and product monographs and Labelling, product development reports, validations, and protocols, Clinical trial documents, MFR, Master and executed Batch records, Packaging records, risk assessment reports.

· Developed and implemented local SOP updates and trained staff on revised global regulatory procedures and Health Canada updates.

· Reviewed and submitted labelling materials (monographs, artwork) in compliance with FDA, HC, and WHO requirements.

• Assisted in drafting and reviewing regulatory submissions for accuracy and compliance, contributing to 15% reduction in review times
• Maintained regulatory documentation archives, ensuring all files were up-to-date and easily accessible
• Supported regulatory team in preparing for audits and inspections, achieving 100% compliance record