Nasar Kardus

Detail-oriented Regulatory Affairs professional in the pharmaceutical industry. Expertise in regulatory submissions (CDSCO/DCGI), clinical trial applications, and dossier preparation. Demonstrated success in managing SUGAM and NSWS portals for Form 12, CT-16, and CT-21 applications. Strong background in regulatory affairs, dossier filing, and ICH-GCP guidelines.

Senior Research Associate - IDRS Labs Pvt. Ltd - Bangalore

(2025-06)

• Executed end-to-end preparation and submission of Import Licenses (Form 12 and CT-16) and CT-21 applications via the SUGAM portal.
• Spearheaded submissions for BE-NOC (CDSCO Form CT-05/16) and resolved regulatory queries within stipulated timeframes.
• Review technical and manufacturing documents, including BMR, MMF, and Process Validation protocols etc.
• Review clinical trial protocols and Bioavailability/Bioequivalence (BA/BE) study documents.
• Monitored approval statuses to ensure product registrations met critical launch deadlines.
• WHO-GMP Application preparation and submission on ONDLS Portal.

Sr. Officer – Regulatory Affairs - Macleods Pharmaceuticals Ltd. - Mumbai

(2022-01 - 2025-06)

• Secured regulatory approvals via SUGAM and NSWS portals for BE-NOC, BE-TL, and Marketing applications.
• Authored dossiers for BE and clinical studies for export markets, ensuring alignment with NDCT Rules-2019.
• Facilitated sample submissions and testing coordination with IPC-CDTL laboratories.
• Enforced clinical data integrity during monitoring visits by reviewing CRFs, ICFs, and source documents.
• Managed post-approval change applications and optimized daily tracking workflows.
• Standardized PI, SPC and PIL documentation for both domestic and ROW markets.

Executive – Medico Regulatory Affairs - IPCA Laboratories Ltd. - Mumbai

(2019-12 - 2022-01)

• Prepared & reviewed package inserts and patient information leaflets for diverse international markets.
• Appraised API and formulation data submissions for compliance with DCGI standards.
• Centralized document collection from R&D, clinical team, QA and ADL departments for consolidated CDSCO filings.
• Administered the archiving process within the Document Management System (DMS) to maintain regulatory readiness.
• Mitigated risks by identifying and resolving queries raised by the DCGI regarding regulatory submissions.

M. Pharmacy - Pharmacology - NDMVP Samaj's College of Pharmacy (2019)

B. Pharmacy - Y. B. Chavan College of Pharmacy (2017)