Regulatory Executive

Key Roles and Responsibilities:

• Follow up with Manufacturer for the documents as per the regulatory guidelines & preparation, compilation of dossiers for submission
• Knowledge of obtaining product permissions, COPP etc.
• Submit the product registration dossier of assigned products to targeted countries as per CTD/ ACTD or eCTD requirements
• File all the required variations and renewals, of assigned products in line with guidelines and checklists as per the plan.
• Respond to queries received from regulatory agencies or business units by ensuring complete and accurate information is provided within predefined timelines.
• Review product labeling, artworks, proof reading etc.
• Maintain various data bases in timely manner.
• Update himself/herself with the relevant & current regulatory requirement of various bodies.
• Provide required support to PV team as and when required
• Ensure support in execution of any projects assigned as per the business needs.