Experience

V. S. International Pvt.Ltd.

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Feb 2018 - Present

  • Handling dossier related submission, lifecycle of registered products and queries • Review the dossiers as per the guidelines for ROW, Africa, South Africa, ASEAN, LATAM (Panama, Costa-Rica, Guatemala, El Salvador and Nicaragua) countries. • Managing the team to resolve these queries in a timely manner • Interacting with the other HODs and staff at plant and marketing on important issue related to registrations and data availability and projects. • Maintaining the monthly repository of registered products, ongoing registration and queries. • Co-ordinating with Marketing and customers to push for registration and queries and overseas requirements for products. • Scheduling meetings and training sessions, or online coaching of team with ongoing activities. • Due diligence and GAP analysis of dossiers for extension to other markets. • Co-ordinating with purchase on CDA (Confidentiality Non-Disclosure Agreement) and drug master files. Show less



Agio Pharmaceutical Ltd

• Executive Regulatory Affairs

  • Apr 2010 - Present



Rusan Pharma Ltd

• India
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Executive Regulatory Affairs

  • Feb 2014 - Jan 2018

  • Dossier preparation for DCGI filing. • Verifying the Licence, COPP’s and artworks as required for the product registration. • Involved in dossier preparation CTD formats • Preparing Tender documents • Dossier preparation for DCGI filing. • Verifying the Licence, COPP’s and artworks as required for the product registration. • Involved in dossier preparation CTD formats • Preparing Tender documents



Maneesh Pharmaceutical Ltd

• Executive Quality Control

  • Dec 1998 - Apr 2010