Sandoz Job opening for Global Labeling Specialist – Apply Now

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 and ensure timely handover of variation packages or response documents to submission teams.
• Interact with country organizations to facilitate timely submission of labeling changes.
• Review and comment on internal or external guidelines and regulations related to regulatory, safety, and legal matters.
• Provide support to Global Labeling Managers on CDS compilation, safety label update evaluation, and document authoring.
• Ensure patient safety through timely and adequate QC reviews for all CDS updates/periodic regular reviews/first version and CDS re-installation of core safety information of marketed products.
• Check signals in the signal management tracking system (cdsDB) and maintain databases and SharePoint sites as defined within the Global Labeling Team.
• Support Compliance Managers in SOP management, PSMF annex preparation, deviations, audits/inspections, and oversee training matrix.
• Coordinate labeling projects or specific safety tasks as assigned and mentor new or less experienced team members as needed.
• Provide technical and administrative support to Global Labeling Managers and Head of Global Labeling.

Key Performance Indicators:

• Timely management of core labeling documents/CDS for assigned products.
• Ensure compliance with Novartis policies and adherence to regulatory internal processes.
• Minimize labeling-related litigation/reputation risks by avoiding unjustified local deviations.
• Provide high-quality regulatory input.
• Performance assessed based on objectives, KPIs, and stakeholder feedback.

Minimum Requirements:

• 3-4 years of relevant experience in Regulatory/Pharmacovigilance domain, preferably in a global organization in generics.
• 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.

Desired Skills:

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

Application Link