NETHRA K
Executive Regulatory Affairs
Chennai
Summary
Determined RA with 3 years of experience in post Approvals of ANDA eCTD Submissions.Collaborated with the compliance team to maintain adherence to global regulatory standards (FDA, EMA, Health Canada, ROW), supporting post-approval submissions, and lifecycle management activities.
Overview
3
3
years of professional experience
Work History
Executive Regulatory Affairs
Strides Pharma Science Ltd
Bangalore
05.2023 - 04.2025
- Prepared and submitted Annual reports and PADER for all approved products, ensuring that product safety, efficacy, and quality data were up to date and compliant with regulatory timelines.
- Worked in the Compliance team to ensure with global regulatory frameworks, including FDA, EMA, Health Canada, and Rest of World (ROW) requirements, timely submission of regulatory filings.
- Supported the post-approval supplements with the preparation and review of regulatory submissions for CMC changes, labeling updates.
- Supported the post-approval supplements and grouped supplements.
- Experienced in compiling and reviewing eCTD Modules (m1-m5).
- Handled REMS, FDARA, PLAIR compilation and submissions.
- Won certificates and coupons in strides pharma for completing the task before due in a limited time period.
Trainee Executive Regulatory Affairs
Strides Pharma Science Ltd
Bangalore
05.2022 - 05.2023
- Supported submission of Annual Reports, PADER's, Supplements, and Amendments to USFDA.
- Collaborated basics with other markets like EMA, ROW and Health Canada.
- Ensured timely updates and tracking of submission statuses using internal databases and regulatory tracking tools.
- Coordinated with cross-functional teams (QA, Manufacturing, R&D) to gather required documents for variations and commitments.
Education
B. PHARM - undefined
SRM Institute of science and technology
01.2020
M.PHARM - Pharmaceutical Analysis
SRM Institute of science and technology
01.2022
Skills
- ANDA Submissions
- Regulatory Documentation (eCTD)
- FDA Communications
- Market Authorization and Approvals
- CMC documentations
- Cross Functional Collaborations
- Risk Assessment and Issue Resolution
- Project Management and Timelines
- Regulatory Strategy and compliance
- RIMS-Basics
Accomplishments
- B-Pharm - 1st class distinction, 2020
- M-Pharm - Gold medalist, 2022, with 95% (9.5 CGPA)
- Certified Lean Six Sigma Green Belt, Authorized by ISEL scored-45/50
- Presented a paper on 'Validated HPTLC method for the estimation of Oxetacaine in Pharmaceutical Formulations', 2021
- Published an article in ELSEVIER Scopus entitled 'Method Development and Validation of Stavudine using UV-Visible Spectrophotometric Method', 2021, in the esteemed journal as a JOURNAL OF HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY, Volume 50, Issue05
Languages
English
Tamil
Hindi
Malayalam
Telugu
Kannada
Projects
- Research and Development - METHOD DEVELOPMENT and VALIDATION ON HPTLC in Stability forced degradation studies, 2021-02-01, 2022-02-28
- Research and Development -Method Development and Validation of Stavudine using UV, 2020
Timeline
Executive Regulatory Affairs
Strides Pharma Science Ltd
05.2023 - 04.2025
Trainee Executive Regulatory Affairs
Strides Pharma Science Ltd
05.2022 - 05.2023
B. PHARM - undefined
SRM Institute of science and technology
M.PHARM - Pharmaceutical Analysis
SRM Institute of science and technology