Sr. Executive/AM -Regulatory Affair-ROW Market

Position :-Regulatory Affairs -ROW Market (Formulation)

Roles & Responsibilities :
 

•  Preparation, Compilation and Review of dossiers in CTD/country specific format for ASIA or LATAM or AFRICA or MENA & CIS Regions.
• Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities.
•  Manufacturing Site GMP Inspection supports with Customers & Cross Functional Departments.
•  Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration.
•  Participating in calls with agents/partners for submission of Dossiers and further updates or requirements if any on product registration.
•  Responding to queries with in the time lines received from client/agency. ...