Posted:3 weeks ago|
Platform:
Work from Office
Full Time
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 6 to 12 years and above of experience in Global Labelling domain
Biocon Biologics Limited
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