Veeva Vault
JYOTI GUPTA
Business Process Lead (Regulatory Affair)
Mumbai
Summary
Highly resourceful and enthusiastic professional with over 5 years of combined experience in business process operations, client communication, and team leadership. Experienced in leading support projects for US mortgage and pharmaceutical domains (Merck). Proven expertise in process improvement, operational efficiency, audit readiness (CQA, IT, iQMS), and documentation (SOPs, Job Aids). Skilled in technical support, ITSM operations, troubleshooting, networking, and technical training delivery.
Overview
5
5
years of professional experience
Work History
Business Process Lead
Tata Consultancy Services (TCS)
06.2023 - Current
- Publishing of different submissions for various markets like US, MOW, GCC and ROW and EU countries.
- Experienced in handling Lifecycle Management (LCM) activities with proven expertise in working on Module 1 to 5 documents for both pre-approval and post-approval regulatory submissions.
- Compilation of the dossiers, organizing, formatting as per country specific requirements. Managed end-to-end publishing and dispatch of complex lifecycle management eCTD, CTD submissions for global markets, including the US, Europe, GCC, MOW and ROW.
- Proficient in various submission formats such as eCTD, NEES, Paper, and e- submissions for applications including NDA, IND, BLA, DMF's, Marketing Applications and Promotional materials submissions.
- Handling of new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets, mainly in US, EU, Japan, Canada Switzerland, Australia.
- Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective.
- Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
- Hands-on experience with submission dispatch through regulatory gateways like USFDA, CESP, and local platforms including CDs, Corporate dispatch through Veeva-vault.
- Handled document-level and submission-level publishing activities bookmarking hyperlinking, setting PDF properties, TOC Creation, Auto-written bookmarks using the ISI toolbox in accordance with ICH guidelines. Create the health authority queries in RIM and track the queries until closure.
- Leading submission publishing team to achieve client goals and ensure timely delivery of quality work.
- Conducting monthly/weekly client meetings to discuss process quality, volumes, and improvements.
- Assisting in training material creation and onboarding of new joiners.
- Managing internal documentation and audit compliances (monthly/six-monthly).
- Successfully faced CQA and iQMS audits with zero non-compliance findings.
- Preparing and maintaining SOPs and Job Aids related to client projects.
Associate Analyst
X L Dynamics Pvt. Ltd
10.2020 - 05.2023
- Worked with a US mortgage company to manage and prepare Final Closing Disclosures.
- Verified tax payments and closing parameters for compliance with US mortgage regulations.
- Ensured accurate and timely delivery of disclosures within defined SLAs.
- Collaborated with Title/Escrow companies to ensure financial accuracy and compliance.
- Supported senior analysts in creating reports with 100% accuracy and timely delivery.
Education
Master of Science - Mathematics
Mithibai College
01.2020
Bachelor of Science - Mathematics
A V College
01.2018
Skills
- Process Improvement & Operational Excellence
- Have knowledge of IT Service & Application Support
- Client Communication & Team Leadership
- Documentation (SOPs, Job Aids, Reports)
- Quality & Compliance (CQA, IT, iQMS Audits)
- Training & Development for New Joiners
Accomplishments
- Successfully faced internal and client audits (CQA, IT, iQMS) with zero non-compliance findings.
- Recognized for process improvement and operational excellence at TCS.
- Managed documentation and compliance processes for large-scale operations.
Additional Information
Strong analytical, communication, and leadership skills., Proactive team player focused on efficiency and quality., Flexible and adaptive to fast-paced environments.
Software
DocuBridge
D2 REDS
RAPS Tool
ServiceNow
Timeline
Business Process Lead
Tata Consultancy Services (TCS)
06.2023 - Current
Associate Analyst
X L Dynamics Pvt. Ltd
10.2020 - 05.2023
Bachelor of Science - Mathematics
A V College
Master of Science - Mathematics
Mithibai College