Global Labeling Specialist

Regulatory Affairs Labeling Specialist role

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 regulatory policy projects and / or labelling projects

Escalate, notify, and resolve any issues that may impact final labelling submission.

Responsible for maintaining internal tracker for CCDS, Non-CCDS and Annual reportable labelling changes and submissions. Responsible for managing Global Labelling Impact Assessment (RLD update / Safety Information Update).

Manage Labelling Team members and direct them to follow as per business process and ensure first time right quality.

Minimum Qualifications and Experience

B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc. Relevant - Minimum 5 to 10 years and above of experience in Global Labelling domain