Performing independent GMP audits as lead auditor & assessment of Suppliers of APIs, Excipients, Advanced intermediates, Starting materials and Packaging materials; Contract manufacturers and Service providers located in India & overseas specially in China, as per current GMP regulations.Supplier development/management activities.Coordinator & performing the self-inspection activities at site.Facing customer audits/regulatory inspections & involved in their compliance related activities.

To strategize from regulatory point of view in coordination with other departments like ARD and CRD for timely submission of DMFs in various countries. To file DMFs and other regulatory documents in global markets like US, EU, Japan and ROW. Responding to the technical queries received from regulatory agencies and customers to facilitate the in time registrations & approvals.Qualification of outsourced API vendors by reviewing their DMFs. Auditing of process packages/development reports received from CRD for adequacy from regulatory point of view.Interdepartmental guidance and decision making on regulatory issues.