labeling specialist

1 week 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

    2 weeks 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

    1 week 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....

  • labeling specialist

    1 week 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

    1 week 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....

  • labeling specialist

    1 week 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....

  • Labeling Specialist

    3 weeks ago


    Bengaluru, India Whatjobs IN C2 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....

  • Labeling specialist

    5 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....


  • 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....


  • Bengaluru, India ScaleneWorks Full time

    Key Responsibilities ?: Author and compile Regional/Country PI as per regulatory authority labelling requirements and GSK process and standards. Author and compile market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards. Provide support to global and local GRA team...

  • Language Specialist

    3 days ago


    Hyderabad, Bengaluru, Mumbai, India Han Digital Solution Private Limited Full time

    Job Description At Han Digital, we are passionate about creating exceptional opportunities for talented professionals. We are currently seeking enthusiastic Language Specialists with proficiency in Italian to join our team and work on exciting projects with leading FAANG companies. If you're looking to build a rewarding career in the tech and AI industry,...