Vaibhav Sancheti

About Vaibhav Sancheti

Regulatory Affairs professional with experience in handling product registrations and regulatory submissions across international markets including **Africa, GCC/Middle East, and South-East Asia**. Skilled in preparing and managing regulatory dossiers in **CTD, eCTD and ACTD formats**, ensuring compliance with country-specific guidelines and regulatory requirements.Experienced in end-to-end **submission management**, including dossier compilation, document review, and responding to **MOH queries** to support successful product approvals and lifecycle management. Proficient in using regulatory tools such as **Sarjen for eCTD submissions**,**Lorenz eValidator** for validation,**SAP** for artwork extraction, and **DMS** for managing site and regulatory documentation.Hands-on experience in **artwork change management**, including raising **AIFs for artwork revisions**, coordinating with internal stakeholders, and ensuring regulatory compliance of packaging materials. Adept at managing **regulatory portals**, maintaining documentation accuracy, and ensuring timely submissions.A collaborative professional with the ability to work effectively with **cross-functional teams** including Quality Assurance, Production, Supply Chain, and R&D to ensure regulatory compliance throughout the product lifecycle.Passionate about regulatory strategy, global compliance, and supporting pharmaceutical products in reaching international markets while maintaining the highest standards of quality and regulatory integrity.

Experience

1. Regulatory Affairs Officer

   Jb

   May 2024 — Present · Mumbai, IN

Education

• SNJB’s Sureshdada jain college of pharmacy, chandwad

  Bachelor of Pharmacy - BPharm, B.pharmacy

  2016 — 2020

• Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur

  M pharmacy, Pharmaceutics