Gaurav Gupta
Experienced Regulatory Affairs Professional | Exploring Regulatory Intelligence & Monitoring workflows across CDSCO, EMA, FDA
- Role
- Senior Manager, Regulatory Affairs at Abbott
- Location
- New Delhi, DL, IN
- LinkedIn followers
- 500 followers
About Gaurav Gupta
Regulatory affairs professional with 16+ years of experience across India and global markets, covering regulatory strategy, new product registrations, lifecycle management, and compliance monitoring.Experience spans India, USA, Europe, Asia-Pacific, Africa, LATAM & CIS markets across diverse regulatory frameworks and submission pathways.Led and supported end-to-end regulatory activities — from dossier authoring (Modules 1–3) and CMC strategy to global submissions, agency interactions, and lifecycle management (variations, renewals, post-approval compliance).Extensive engagement with regulatory authorities such as CDSCO, with exposure to global regulatory expectations including the US FDA and other international agencies, while collaborating closely with R&D, quality, supply, and business teams.A key focus area has been regulatory intelligence and impact assessment —monitoring evolving guidelines, interpreting changes, and translating them into actionable inputs for compliance and business continuity.Over time, this has highlighted a recurring challenge:Tracking regulatory updates across multiple authorities is far more fragmented and manual than it seems in practice.I’ve been increasingly focused on understanding this space —how teams monitor updates, manage information flow, and ensure critical changes don’t get missed amidst growing volume and complexity.Particularly interested in:– Regulatory intelligence & monitoring workflows– Change tracking across CDSCO, US FDA, EMA, and other global authorities– Practical challenges in interpreting and operationalizing regulatory updatesAlways open to exchanging perspectives with professionals working in regulatory affairs and related domains.
Experience
Senior Manager, Regulatory Affairs
Sep 2022 — Present · New Delhi, IN
Education
Guru Jambheshwar University
Bachelor's degree, Pharmacy
Rajasthan University of Health Sciences, Jaipur
Master of Pharmacy , Pharmaceutical Chemistry
Skills
- Pharmacy
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Filings
- Anda
- Generic Programming
- Formulation
- Regulatory Requirements
- Regulatory Affairs
- Gmp
- Regulatory Submissions
- Validation
- Ectd
- Dissolution
- Pharmaceutics
- Capa
- Glp
- Cmc
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