Experience

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  S kant healthcare ltd.

  Feb 2011 - Oct 2014

  Sr. executive regulatory affairs

  Dossier Compilation for African, Latin American and Asian markets, Query Responding, Tender Handling, Pre-Qualification questionnaire, CTD & ACTD Dossier Preparation, Reviewing of documents as per CTD guidelines, Artworks checking, Handling FDA Applications, Handling Quality Complaints, Filling Applications for Variation & Renewals.

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  Johnson & johnson

  Nov 2014 - Mar 2017

  Regulatory affairs

  Dossier Preparation - CTD - ACTD format. NDA applications for RoW countries.DCGI applicationsResponding to queries by Health Authorities.Handling various FDA applications Product Lifecycle Management.

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  Merck group

  Mar 2017 - Dec 2020

  Associate regulatory affairs

  • Registration of drugs.• Updating trackers and keeping track of submissions. • To maintain audit compliance.• Interaction with different stake holders for collating documents, preparing and submitting application for life cycle management of products as per regulatory requirements to DCGI: ensuring timely submission of updated Smpc (package inserts) providing assistance in SNDA Applications. Ensuring timely submission of variation applications, renewal applications.• Preparing and submitting NDA application for Sri Lanka, Bangladesh, Pakistan and Maldives.• Life cycle management activities for Sri Lanka, Bangladesh, Pakistan and Maldives – Renewal applications and variation filings.• Providing tender support. Show less

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  Pfizer

  Dec 2020 - now

  Assistant manager