Payal Lanje

Regulatory Affairs professional with 2.5+ years of experience across pharmaceutical and FMCG industries specializing in labeling compliance, artwork lifecycle management, regulatory publishing (eCTD), and global submission support. Experienced supporting FDA and EMA regulatory activities, coordinating cross-functional stakeholders, and delivering compliant product documentation within strict timelines. Proficient in Veeva Vault and regulatory systems with strong attention to compliance and operational excellence.

Regulatory Artwork & Data Analyst - Capgemini - Mumbai, India

(2025-05 - 2025-12)

• Managed end-to-end artwork data orchestration for FMCG product launches, ensuring compliance with regional labeling regulations
• Coordinated regulatory, marketing, legal, and supply chain stakeholders across artwork approval workflows to support on-time delivery of FMCG product launches.
• Tracked artwork lifecycle milestones, proactively identifying risks and ensuring timely delivery of projects
• Conducted detailed reviews of artwork data to mitigate compliance risks and maintain accuracy across regulatory requirements
• Consolidated complex regulatory and technical data into a single, reliable source of truth

Regulatory Affairs Officer - IQVIA - Bangalore, India

(2023-08 - 2024-08)

• Prepared and published eCTD-compliant regulatory submissions supporting FDA and EMA filing requirements.
• Coordinated the compilation and submission of regulatory dossiers, including INDs and clinical documents
• Developed and reviewed labeling components such as Patient Information Leaflets (PILs) and packaging materials
• Supported artwork preparation and review for regulatory submissions, ensuring compliance with global standards
• Collaborated with cross-functional teams to ensure timely and accurate submission processes

Regulatory Affairs Intern - GSK - Bangalore, India

(2022-08 - 2023-08)

• Supported regulatory labeling activities including Company Core Data Sheets (CCDS/CLDs) and EU Product Information
• Assisted in linguistic reviews and translation processes for regulatory documents
• Maintained regulatory documentation and ensured compliance with internal and external standards
• Provided administrative and operational support to senior regulatory professionals

Master of Science - Drug Regulatory Affairs - Manipal (2023)

Bachelor of Science - Pharmacy - Institute of Pharmaceutical Education And Research (2020)