Manager - 1

Manager-1 position at Sun Pharmaceutical Industries Ltd. Responsible for reviewing data, compiling dossiers, and submitting to various health authorities. Provides regulatory support and manages a team.

Requirements

• Reviewing all data and documents related to product registrations
• Compiling registration dossiers for submission to various health authorities
• Preparing responses to deficiency letters
• Maintaining life-cycle / post approval changes for drug product registration dossiers
• Providing regulatory support to cross functional departments
• Preparing and submitting scientific advice to various health authorities
• eCTD compilation, verification and submission through electronic gateway
• Reviewing, preparing and submitting annual reports to US FDA
• Reviewing, preparing and submitting post approval supplements to US FDA
• Reviewing of the plant change control and established the variation strategy for submission
• Review of query response prepared and compiled by regulatory associates
• Review of all the documents received from stake holder for dossier compilation, Query response and Life cycle management
• Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities