KISHOREKUMAR SUBRAMANIAN
Toronto
Summary
Regulatory affairs professional, over 4 years of experience with strong analytical and problem-solving skills. Proven ability to navigate complex regulatory environments and ensure compliance with industry standards. Focused on collaborative team efforts and adaptable to evolving requirements. Skilled in regulatory documentation, risk assessment, and stakeholder communication. Reliable and results-driven professional prepared to make significant impact.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Intern
Purcell Global Pvt Ltd
03.2024 - 07.2024
- Developed a comprehensive regulatory strategy for an innovative drug-device combination product featuring AI & ML-driven inhaler technology, achieving full compliance with CMDR and ISO 13485 standards ahead of timeline expectations
- Developed a comprehensive pre-clinical trial framework that integrated assessments of drug safety, efficacy, including Medical Device License Application (MDL)regulatory risk assessments and clinical data compilation, ensuring compliance with both medical device and pharmaceutical regulations
Regulatory Affairs Executive
Strides Pharma Science Limited
09.2020 - 09.2022
- Prepared and reviewed Quality and administrative documents like Product labeling, CMC documentations for FDA, HC and WHO regulatory submissions.
- Led eCTD submissions (Modules 1-5) for FDA, Health Canada, and WHO, ensuring regulatory compliance and streamlining product approvals.
- Prepared, reviewed and submitted critical post-approval modifications (PAS, CBE, variations and NOC) to align with regulations while addressing key compliance updates within a tight timeline.
- Formulated and submitted comprehensive responses to regulatory inquiries including labeling and quality changes from FDA, Health Canada (HC), and WHO; ensured compliance with all documentation requirements.
- Scrutinized and authorized a comprehensive range of cGMP documentation, including DMFs and product monographs; ensured regulatory compliance which facilitated smooth submissions.
- Collaborated with cross-functional teams to streamline submission preparation process for regulatory filings.
Regulatory affairs Co-ordinator
Lifecell International private Limited
10.2016 - 09.2020
- Led regulatory submissions and compliance reports for domestic and ROW markets, ensuring adherence to evolving industry regulations.
- Streamlined packaging and promotional content revisions, reducing consumer inquiries and enhancing clarity.
- Collaborated with cross-functional teams to implement regulatory changes, improving operational efficiency and ensuring compliance across 10 product lines.
- Conducted inspection readiness assessments and internal training, maintaining a 98% compliance accuracy rate and improving team awareness by 35%.
Education
Master of Science - Regulatory Affairs (Drugs, Biologics & Medical Devices)
Northeastern University
07.2024
Bachelor of Technology - Industrial Biotechnology
Anna University
05.2014
Skills
- Regulatory Expertise, submissions (Module 1-5)
- FDA,EMA, HC regulations
- Post-market compliance
- Product Labeling
- CAPA, Root Cause analysis, Risk management
- Project management
- MS Office, Excel, word, Adobe PDF
- Regulatory tools- PLM, DMS, LIMS, Educe, eLorenza, SAP, Trackwise, SPL
- Electronic document management
- Electronic document review systems
- GMP, GCP, GLP, ICH, ISO 13485, ISO 9001, ISO 14971
Websites
Certification
- Regulatory Affairs Certification Program (In Progress)
- Lean Six Sigma | Project Management Institute
- ISO 9001: 2015
- Understanding How Medical Devices Are Regulated in Canada | Health Canada
- Project Management and Productivity Tools (Word, Advanced Excel, PowerPoint, Outlook, Adobe Acrobat)
Personal Information
Title: Regulatory Affairs Specialist or Senior Regulatory affairs Associate
Timeline
Regulatory Affairs Intern
Purcell Global Pvt Ltd
03.2024 - 07.2024
Regulatory Affairs Executive
Strides Pharma Science Limited
09.2020 - 09.2022
Regulatory affairs Co-ordinator
Lifecell International private Limited
10.2016 - 09.2020
Bachelor of Technology - Industrial Biotechnology
Anna University
- Regulatory Affairs Certification Program (In Progress)
- Lean Six Sigma | Project Management Institute
- ISO 9001: 2015
- Understanding How Medical Devices Are Regulated in Canada | Health Canada
- Project Management and Productivity Tools (Word, Advanced Excel, PowerPoint, Outlook, Adobe Acrobat)
Master of Science - Regulatory Affairs (Drugs, Biologics & Medical Devices)
Northeastern University
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