labeling specialist

4 weeks ago

Bengaluru, India Biocon Biologics Full time

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

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