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Regulatory Artwork & Data Analyst
Regulatory Affairs Specialist with Capgemini FMCG artwork compliance experience and IQVIA dossier submissions for FDA and EMA.
United KingdomRegulatory Artwork & Data Analyst at Capgemini
Managed end-to-end artwork data orchestration for FMCG product launches, reviewing and approving labels, packaging, and artwork for compliance across multiple regional markets. Maintained a structured document repository and tracked submission progress against milestones.
Artwork ReviewRegulatory ComplianceDocument ManagementStakeholder ManagementProject TrackingData Integrity
Prepared, compiled, and maintained regulatory dossiers and eCTD-compliant submission packages for FDA and EMA filings, including INDs and clinical study documentation. Developed and reviewed labelling components for compliance with global regulatory standards.
Regulatory SubmissionseCTDFDA
Master of Pharmacy in Drug Regulatory Affairs from Manipal College of Pharmaceutical Sciences, Manipal University, completed in 2023.
Master of Pharmacy in Drug Regulatory Affairs from Manipal College of Pharmaceutical Sciences, Manipal University, completed in 2023.
Bachelor of Pharmacy from the Institute of Pharmaceutical Education and Research, Wardha, completed in 2021.
Bachelor of Pharmacy from the Institute of Pharmaceutical Education and Research, Wardha, completed in 2021.
Supported global regulatory labelling activities, including Company Core Data Sheets and EU Product Information documents, maintaining version-controlled documentation. Assisted with linguistic reviews and translation validation for regulatory and labelling documents.
Regulatory AffairsLabellingCCD SEU Product InformationDocument ManagementTranslation Validation
Profile sourced from Himalayas.