Ashok Chaudhary

About Ashok Chaudhary

Ensure preparation, validation, dispatch and submission of compliant and high quality initial, 2nd wave and maintenance Regulatory filings according to submission plans. Update respective Regulatory systems for Registration Management, Publishing and Document Management. Support the Global Regulatory teams during the product development phase and provide input as appropriate Support regulatory teams during the submission process in all administrative and technical steps according to global procedures Prepare and dispatch/submit documentation packages for all kinds of submissions involved with EU (Type-I,II),US (NDA, Annual Reports, PADER etc.) LATAM, SIR and other region(s) in compliance with Health Authority requirements Archiving activities and associated tasks for assigned Regulatory submissions within agreed timelines. Ensure eCTD lifecycle maintenance according to ICH and regional specifications Ensure timely update of submission data in the regulatory information management databases and verify that the data is kept compliant Be involved in the timely and efficient processing of regulatory, submission-relevant documents like M1, eAFs, COPPs, GMP Certificates, QP declaration etc. Maintain communication network with regulatory functions like RERs, RGLI and country organizations and non-regulatory stakeholders according to guidance documents. Ensure escalation procedures are followed in case of issues and delays Involved in document preparation activities like scanning, bookmarking, linking and other activities to ensue document submission readiness Involved in document bulk upload activities as well. Business expert for publishing tool SELECT docuBridge, eCTD champion for lifecycle managementFor Bio-pharmaceuticals Publishing (Bio-similars): Maintaining end-to-end lifecycle & product owner of various bio-similar products available in the market. Publishing of medical devices submissions for various markets (MOW, US, Canada, EU) Maintaining regulatory activities for new submissions, renewals, variations, invalidations, DL responses. Working with cross-functional stakeholders to initiate regulatory strategy, Creating a workflow, providing support to DMS activities. Interact with authors/reviewers and responsible site lead with respect to delivery of CMC documents required for regulatory submissions Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC and/or Device submissions and related communications in the document management system

Experience

1. Senior Regulatory Affairs Specialist

   Sandoz India

   Oct 2025 — Present · Hyderabad, IN

Education

• Attar Singh Yadav Memorial Education Trusts Siddhant College of Pharmacy,Pune

  Bachelor of Pharmacy (B.Pharm.), Pharmacy

  2010 — 2014