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.