Payal Lanje
@payallanje
Regulatory Affairs Specialist with Capgemini FMCG artwork compliance experience and IQVIA dossier submissions for FDA and EMA.
United KingdomWhat I'm looking for
At Capgemini, I managed FMCG artwork data orchestration for product launches, reviewing and approving labels, packaging, and artwork for compliance across regional markets.
I maintained an artwork and regulatory data repository, tracked milestones across concurrent projects, and verified product claims, ingredient declarations, warnings, and instructions for use.
At IQVIA, I prepared and maintained regulatory dossiers and eCTD-compliant submission packages for FDA and EMA filings, including INDs and clinical study documentation. I also reviewed labelling components and supported artwork approvals against FDA, EMA, and ICH guidelines.
At GlaxoSmithKline (GSK), I supported global regulatory labelling activities, maintained version-controlled documents, and assisted with linguistic reviews and translation validation. I’m seeking a UK-based Regulatory Affairs role in pharmaceuticals, medical devices, food supplements, nutraceuticals, cosmetics, or consumer healthcare.
Experience
Work history, roles, and key accomplishments
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.
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.
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.
Education
Degrees, certifications, and relevant coursework
Manipal College of Pharmaceutical Sciences, Manipal University
M.Pharm, Drug Regulatory Affairs
Master of Pharmacy in Drug Regulatory Affairs from Manipal College of Pharmaceutical Sciences, Manipal University, completed in 2023.
Institute of Pharmaceutical Education and Research, Wardha
B.Pharm, Pharmacy
Bachelor of Pharmacy from the Institute of Pharmaceutical Education and Research, Wardha, completed in 2021.
Tech stack
Software and tools used professionally
Availability
Location
United KingdomAuthorized to work in
Salary expectations
Social media
Job categories
Skills
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