Regulatory Labelling Manager

3 weeks ago

bangalore, India Biocon Biologics Full time

Labelling Manager

Bangalore, India


Job Description:

  • 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.


Required/Qualifications:

  • B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
  • A minimum of 7 years of regulatory labelling experience, especially EU labelling.
  • Artwork management, commercial launch & SPL is a mandate.

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