Regulatory Affairs Specialist

Key Responsibilities:

 Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products.

 Ensure Artwork Management for Initial Submission / Commercial Launch activities in coordination with CFT team.

 Responsible for Promotional Material Review and participate in CFT meetings representing Regulatory on strategic decisions by ensuring no misleading information.

 Responsible to Coordinate with External Vendor to ensure Translations documents are prepared / reviewed to support Global Regulatory Submissions.

 Responsible for SPL Preparation for Initial Submission / Labelling Response and Drug Listing for Approved Products as per business/agency timeline.

 Change management process of CCDS, Non-CCDS and Annual reportable labelling changes.  Analysis of competitor information (e.g., labels, approval packages) for re...