Minu K

WORK HISTORY

EDUCATION

ABOUT MINU K

Energetic and results-driven Regulatory Affairs professional with 9 years of comprehensive experience in the pharmaceutical industry, specializing in new product submissions, post-approval changes, and lifecycle management. Holds a Master’s degree in Pharmacy with a specialization in Pharmaceutical Quality Assurance.1. Regulatory Affairs & Product Launch Submissions- Experienced in preparing and submitting regulatory dossiers for UK National, IRP, DCP, and MRP procedures, with submissions to major health authorities including the MHRA, EMA, and FDA, CDSCO. Skilled in managing new applications, post-approval variations, licence renewals, site renewals, annual reports, and PBRER scheduling.Proficient in overseeing change controls, artwork approvals, risk assessments, and developing regulatory strategies across supply chain management, clinical trials, and bioequivalence/bioavailability studies.2.CMC Strategy & Compliance Summary- expertise in developing and executing global CMC regulatory strategies across all stages of the product lifecycle. Skilled in preparing and reviewing CTD Modules 2 and 3, including authoring Quality Overall Summaries (QOS – M2.3) and country-specific dossiers. Actively engaged with Health Authorities and internal teams to resolve CMC and quality-related issues for both development and marketed products.3. Regulatory Guidelines and Standards-Strong command over global regulatory guidelines and pharmacopeia\'s, including ICH (quality and safety), GMP, GDP, GCP, USFDA, MHRA, EMA, WHO, BP, IP, USP, and the Orange Book.