Abhishek S
Regulatory affairs officer | CMC | eCTD Publishing | Veeva | Ex.Adcock
- Role
- Regulatory Affairs Associate at Parexel
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Abhishek S
CMC Ensure compilation, review & submission of high-quality e-CTD dossier including labeling and filing Variations to South Africa as per specific country requirements (as per EMA & SAHPRA-South African Health Products Regulatory Authority and ROA markets requirements) Review technical documents like process validation, AMVP, AMVR, PDR, & Stability & composition, etc, labeling, batch records, specifications, & MOAs for compliance with the applicable regulations and policies. Submission of query responses, coordinating with internal departments wherever the supporting documents for query responses. Liaise rigorously with RD & I/ manufacturing sites/ customers/ principals in order to get documents for timeous dossier compilation. Preparation of Annual Product Quality Review (APQR) summary report for QA department and Preparation of implementation notifications for amendments like (Type IA, Type IAIN, Type IB, and Type II) Ensure preparation of the quality response to agency queries timeously suitable to be filed. Review of Drug Master File (DMF), Certificate of Suitability (CEP), and all other relevant documentation according to SAHPRA / specific country requirementPUBLISHING- Validating of submissions using validation tool LORENZ eValidator version 22.1 was used to check compliance Performing document-level publishing activities troubleshooting document issues and performing quality control checks for submission-ready documents as per the agency guidelines Publishing of regulatory submissions for South Africa Submissions of eCTD dossiers through software like Lorenz docuBridge (dB). Good knowledge of eCTD Publishing by using Adobe Acrobat DC & Standard PDF properties, document preparation, OCR, rendering, and following1. Formatting of Word documents as per authority requirements Uploading documents & Basic compilation. Submission Quality Control and published output for completeness & correctness in formatting and navigation. Document Versioning and Hyperlinking (Well versed with blue text & destination & text hyperlinks & QC of hyperlinks. Content Re-use-Part applications. Life cycle management and application cloning and Validation. Optimizing and submission building using Lorenz docuBridge tool. Quality review of all of dossier as per current SAHPRA/specific country guidelines.
Experience
Regulatory Affairs Associate
Mar 2024 — Present · Karnataka, IN
Education
RR College Of Pharmacy
Bachelor of Pharmacy - BPharm, Pharmacy, Pharmaceutical Sciences, and Administration
2016 — 2019
RR COLLEGE OF PHARMACY
Master in Pharmaceutics, Pharmaceutics
2019 — 2021
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