Adarsh Sharma

Pharmaceutical Regulatory Affairs and Quality Control professional with 3 years of experience in CTD/eCTD dossier preparation, GMP/GLP quality systems, and regulatory documentation for CDSCO, US FDA, and EMA submissions. PG Diploma holder in Drug Regulatory Affairs (Jamia Hamdard University) with hands-on expertise in ICH Q1–Q10 stability studies, analytical method validation, and CAPA/change control management. Known for accurate, GMP-compliant documentation and strong cross-functional collaboration with QA, Production, and R&D teams.

Seeking a Regulatory Affairs Associate or Executive role to apply proven compliance, documentation, and quality-systems skills.

Junior Technical Officer – Quality Control - Arbro Pharmaceuticals Pvt. Ltd. - New Delhi, India

(2023-07)

• Performed QC release testing on 50+ commercial pharmaceutical batches, achieving 100% compliance with pharmacopoeial and GMP standards.
• Operated and calibrated UV-Vis Spectrophotometer, FTIR, Karl Fischer Titrator, Auto Titrator, and Polarimeter per SOP schedules.
• Authored and revised SOPs, analytical test methods, and batch manufacturing records, strengthening GMP-compliant documentation.
• Compiled ICH Q1A–Q1F stability data packages that supported CDSCO dossier submissions and export market regulatory filings.
• Investigated deviation reports and CAPA records, driving root cause analysis and maintaining regulatory inspection readiness.
• Partnered with QA, Production, and R&D teams to resolve non-conformances in line with US FDA and CDSCO guidelines.
• Compiled technical documentation and response dossiers that supported mock regulatory audits and internal GMP inspections.

R&D Associate – Product Development - Reckitt Benckiser India Pvt. Ltd. (Lysol) - India

(2024-03 - 2024-04)

• Contributed to an international R&D team's Lysol disinfectant formulation project, running efficacy and safety testing per WHO/EU guidelines.
• Supported technical documentation, labeling compliance, and stability evaluation, contributing to dossier-ready data packages.

Analytical Research Associate – TB Vaccine Project - Serum Institute of India - India

(2024-01 - 2024-02)

• Evaluated TB vaccine candidates analytically, supporting ICH-compliant stability assessment and pharmacovigilance data collection.
• Compiled regulatory submission-ready test protocols and quality data summaries adhering to GLP standards.

PG Diploma - Drug Regulatory Affairs - Jamia Hamdard University (2024 - 2025)

Bachelor of Pharmacy - Pharmacy - Pt. BD Sharma University (2018 - 2022)

Industrial Training - Auriga Research Pvt. Ltd. (2022-09 - 2022-10)