labeling specialist

3 days ago

Bengaluru, India Biocon Biologics Full time

Regulatory Affairs Labeling Specialist roleKey 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 ExperienceB. Pharmacy / M. Pharmacy / B.Sc. / M.Sc. Relevant - Minimum 5 to 10 years and above of experience in Global Labelling domain

  • labeling specialist

    4 days 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...

  • labeling specialist

    2 days ago

    Bengaluru, India Biocon Biologics Full time

    Regulatory Affairs Labeling Specialist roleKey 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....

  • labeling specialist

    2 days 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...

  • labeling specialist

    19 hours 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...

  • labeling specialist

    3 days ago

    Bengaluru, India Biocon Biologics Full time

    Regulatory Affairs Labeling Specialist roleKey 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....

  • labeling specialist

    4 days ago

    Bengaluru, India Biocon Biologics Full time

    Regulatory Affairs Labeling Specialist roleKey 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....

  • labeling specialist

    4 days ago

    Bengaluru, India Biocon Biologics Full time

    Regulatory Affairs Labeling Specialist roleKey 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....

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    2 days 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...

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    7 days ago

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