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Global Labeling Specialist (On site) - Sandoz

Date Posted: Apr 26, 2024
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Job Detail

  • Location:
    Achampet, Telangana, India
  • Company:
    Sandoz
  • Type:
    Full Time/Permanent
  • Shift:
    No
  • Career Level:
    No
  • Positions:
    No
  • Experience:
    No
  • Gender:
    No Preference
  • Degree:
    Masters
  • Apply Before:
    May 26, 2024
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Job Description

Major accountabilities:

  • Update core texts SmPCs/PLs/Labelling for EU registration procedures MRP/DCP/CP in English for variations and renewals.
  • Coordinate translations for CPs.
  • Ensure in-time hand-over of variation package or response documents to submission teams.
  • Interact with country organizations to ensure timely submission of labelling changes.
  • Review and comment on internal or external guidelines and regulations on regulatory, safety and legal topics.
  • Support to Global Labelling Managers on CDS compilation, safety label update evaluation and authoring of documents.
  • Ensures patient safety through timely and adequate QC reviews for all CDS updates/periodic regular reviews/first version and CDS re-installation of the core safety information of marketed products.
  • Checks signals in the signal management tracking system (cdsDB), including reference product information and regulatory authority communication for review of CDS and related Expert Statements.
  • Screen and maintain databases and sharepoint sites as defined within the Global Labelling Team.
  • Supports Compliance Managers in SOP management, PSMF annex preparation, deviations, Audits/Inspections and oversee training matrix.
  • Coordinate labelling projects or specific safety tasks as assigned.
  • As needed, mentors new or less experienced team members on regulatory submissions or safety label update evaluation.
  • Technical and administrative support to Global Labelling Managers and Head of Global Labelling.

Key performance indicators:

  • Timely management of core labelling documents/CDS for assigned products.
  • Ensure compliance with Novartis policies and adherence to regulatory internal processes.
  • Minimize labelling related litigation/reputation risks by avoiding unjustified local deviations.
  • Provide high quality regulatory input.
  • Performance is assessed based on objectives, KPIs and stakeholder feedbacks.
  • 3-4 years in role to independently manage various projects and gain experience on CDS compilation for products.

Minimum Requirements:

  • At least 3-4 years of relevant experience in Regulatory/Pharmacovigilance domain with an exposure of working in a global organization in generics is preferred.
    • Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) - Masters or Bachelors.

Work Experience:

  • Cross Cultural Experience.
  • Functional Breadth.
  • Collaborating across boundaries.

Skills:

  • Detail Oriented.
  • Labeling Documentation.
  • Labeling Regulations.
  • Operational Excellence.
  • Regulatory Compliance.
  • Safety.

Languages :

  • English.
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Skills Required

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Company Overview

Sandoz
, India
0 Current Jobs Openings

Sandoz is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s... Read More

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