Lead Consultant - Genpact
(2025-09)
- Executed multiple post-approval variations (Type IA, IB, II) for EU (EMA), UK (MHRA), emerging markets.
- Performed gap analysis of regulatory documents to identify non-compliance areas and recommend regulatory strategy.
- Authorized CMC documents for Module 2 and 3.
- Managed Change controls through Synaps and ensure impact assessment
- Utilized Veeva Vault RIM for document management and approval workflows.
- Collaborated with cross-functional teams and external stakeholders for project submission and regulatory compliance.
- Delivered projects within defined timelines and ensure compliance with SOP and regulatory guidelines.
Senior Officer - Brillpharma Pvt. Ltd.
(2023-06 - 2025-09)
- Successfully submitted variations (Type IA, IB & II) and Bromi submissions via MRDC and National procedures.
- Drafted CMC documents and reviewed technical documents - Module 3 and Quality Overall Summary.
- Contributed to preparation of MA Applications.
- Drafted responses to VCR and ensure timely submissions and approvals.
- Initiated of Change control procedure (through QAMS) & identified impact of changes & arrange supporting documents for submission.
- Maintained Product License Files and internal regulatory databases.
Senior Officer - MacLeods Pharmaceuticals Ltd.
(2021-12 - 2023-06)
- Prepared and submitted (Module 1-5) CTD dossiers for new and post approvals across East & West Africa Markets.
- Performed critical review of CMC documentation to support pre and post approvals
- Managed Change controls through Trackwise software and ensure impact assessment.
- Independently handled deficiency responses.
- Coordinated with cross-functional teams and maintained internal regulatory databases.
Executive - Coral Laboratories Ltd.
(2020-09 - 2021-11)
- Prepared and submitted CTD dossier submissions and Amendments to receive approval for East & French West Africa and CIS regions.
- Evaluated change controls and finalize appropriate strategy.
- Compiled and submitted post-approval supplements as and when necessary.
- Coordinated with internal teams and stakeholders for documentation.
- Prepared responses to deficiencies received from authority.
- Reviewed and release of commercial finished products.
- Managed applications Product Permission, Manufacturing License and free sale certificate.
- Supported product registration by arranging samples and documentation.
Executive - Prism Life Sciences Ltd.
(2017-07 - 2020-04)
- Prepared and submitted CTD dossiers for registration & renewal in Sri Lanka, Haiti, Guatemala, Uzbekistan, Kenya markets.
- Reviewed of the quality and analytical data as per the pharmacopoeia, specifications, MOA, batch records, Stability studies, finished product / Packaging material data to submit responses to deficiencies.
- Reviewed labeling & packaging-marketing-promotional materials & get it approved from respective authorities.
- Coordinated with internal teams to arrange finished product, working standards and reference standards.
- Reviewed supportive documents (Commercial Invoice, Packing List, FPCOAs etc.) required for dispatch of Shipment.
- Worked for Application of Trademark (India).
Officer - Flamingo Pharmaceuticals Ltd.
(2016-01 - 2017-02)
- Prepared CTD + Country specific dossiers for registration & renewal processes.
- Applied COPP, FSC, Mfg. LIC. Applications on FDA portal.
- Coordinated with QA, QC department for regulatory documents
