Shreya Sawant

About Shreya Sawant

Regulatory Affairs professional with 9 years of experience in global submission planning and publishing within the pharmaceutical industry. Currently at Tata Consultancy Services, I specialize in delivering high-quality, timely submissions across EMEA and APAC regions, with deep expertise in eCTD, ICH guidelines, and country-specific regulatory requirements.Over the years, I’ve led and supported complex regulatory projects at TCS, Genpact, and Cipla, bringing end-to-end experience in submission strategy, planning, publishing, validation, and error resolution. I’m proficient in tools like Liquent Insight, Veeva Vault, Lorenz Validator, and EURS Validator.Recognized for my attention to detail, problem-solving mindset, and ability to perform under tight deadlines, I’ve received honors such as the Star Performer Award, Quality Champion Award, and multiple client appreciations for excellence and professionalism. Always open to networking, knowledge-sharing, and exploring opportunities in global regulatory strategy, digital transformation in RA, and submission innovation.

Experience

1. Business Process Lead

   Tata Consultancy Services

   Jan 2022 — Present · Thane, IN

   Lead submission publishing activities for EMEA and APAC regions, ensuring compliance with eCTD, ICH guidelines, and region-specific regulatory requirements.2. Prepare, compile, publish, and dispatch submission-ready dossiers using industry-standard tools such as Veeva Vault, Liquent Insight, Lorenz Validator, and EURS Validator.3. Perform validation, troubleshoot errors and warnings, and execute post-publishing activities including hyperlinking, TOC creation, and bookmarking.4. Support MRP, DCP, CP, and National regulatory filings for the EU, coordinating closely with global RA teams to ensure timely and accurate submissions.5. Manage end-to-end submission planning, tracking, component assembly, and publishing requests while meeting defined quality and turnaround time (TAT) targets.6. Liaise with cross-functional contributors to ensure the timely delivery of dossier components; escalate and resolve submission roadblocks as needed.7. Provide documentation, process guidance, and support for regulatory audits and inspections.8. Maintain and update project management systems with planned submission timelines and health authority communication logs.Software used: Liquent Insight, Veeva Vault, EURS, Lorenz and Insight Validator, ISI ToolBox, Citation Wizard, IQVIA Toolbox, ORION, SPARS, PSPM, LUCY, REDS

Education

• Mumbai University Mumbai

  Masters Degree, Quality Assurance

  2015 — 2017