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.

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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.

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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.

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• 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.

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