Novartis is hiring B. Pharma/ M. Pharma as a Global Labeling Specialist – Apply Now

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Are you a talented B. Pharma, M. Pharma, B. Sc, or M. Sc professional seeking a dynamic career opportunity? Novartis, a global healthcare leader, is hiring for the position of Global Labeling Specialist in the vibrant Hyderabad region. Join Novartis and contribute to groundbreaking healthcare solutions while advancing your career in a leading pharmaceutical company. Explore this exciting role where your expertise will help shape the future of global healthcare. Apply now to be part of a team that’s dedicated to making a difference.

Position: Global Labeling Specialist

Minimum Requirements for Global Labeling Specialist at Novartis

  • 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 for Global Labeling Specialist at Novartis

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

Skills for Global Labeling Specialist at Novartis

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

Job Description for Global Labeling Specialist at Novartis

Provides the labeling/artwork strategy, regulatory intelligence and knowledge which are required to develop, market, and maintain products. Provides strategic labeling input and support for global development projects and/or marketed products. Reviews labeling change information, and ensures that it is supported by the data and consistent with the application. Supports and assists the development & participates in negotiations on later stage products with regulatory agencies on approval of label.

Major accountabilities for Global Labeling Specialist at Novartis

  • 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 for Global Labeling Specialist at Novartis

  • 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.
Location Hyderabad
Job Type Full Time
Job ID REQ-10002157
Apply Online Click Here


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