Suraj Kashyap
Regulatory Affairs Leader | Drugs & Devices | eCTD Publishing | Labelling | RIMS | M&A Projects | Project Management | Business Analysis | Agile | GEHC* | Ex-MSD | Ex-CGI | Ex-Parexel | Ex-Indegene
- Role
- Lead Specialist - Regulatory Affairs at GE医疗
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Suraj Kashyap
Dedicated and results-driven Regulatory Affairs Professional with 8+ years of experience in Regulatory Operations, Project Management, Strategy, and Submissions across global markets (USFDA, EMA, TGA, HC, MHRA, GCC etc.).Experienced in end-to-end regulatory submissions, including: • Clinical trial submissions: Original Applications, Amendments (Protocol, IB, IMPD, ICF, CSR, DSUR, Protocol deviations, etc.) • Marketing submissions: IND, CTA, NDA, BLA, DMF, MAA, and EU procedures (CP, DCP, MRP, NP) • Lifecycle management: Supplements (CMC & Labelling), Renewals, PSURs, Safety reports, Ad-Promo, PADER, Variations (Type IA/IB/II), Transfers, and ExtensionsProficient in eCTD publishing and document management, with strong knowledge of ICH guidelines and submission standards. Skilled in dispatching submissions via WebTrader, ESG (USFDA), Synplicity, and CESP (EMA).Expertise in: • Modules M1–M5 (with deep focus on M3 – CMC submissions) • Global labelling and artwork management • RIMS data migration, validation • Document publishing (formatting, submission readiness checks, content and gap analysis)Hands-on with tools such as Insight Publisher, DocuBridge, Veeva Vault, SmartDesk, Adobe Acrobat ISI Toolbox, Acuta, eXTEDO EURS Validator, Insight Validator, and Lorenz Validator.I’m passionate about maintaining global compliance standards, optimizing submission efficiency, and driving successful regulatory outcomes.
Experience
Lead Specialist - Regulatory Affairs
Oct 2025 — Present · Bengaluru, IN
Education
Bangalore University
Master of Science, Biotechnology
Government Science College, Bangalore
BSc
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