Specialist Global Labeling (m/f/d)

at  Sandoz

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!

Essential Requirements:

• Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) - Masters or Bachelors.
• Good written and spoken English. Local language is an advantage.
• 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.
• Experience in managing databases; creating and maintaining share points; with added skills in Excel, is preferred.
• Exposure towards project management is a plus.
• Well-structured, result-oriented, highly self-committed, resilient, flexible, team player.
• High operational excellence orientation

YOUR KEY RESPONSIBILITIES:

Your responsibilities include, but not limited to:

• Update core texts SmPCs/PLs/Labeling 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 labeling changes.
• Review and comment on internal or external guidelines and regulations on regulatory, safety and legal topics.
• Support Global Labeling Managers with regards to CDS compilation, safety label update evaluation and authoring of documents.
• Ensure 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.
• Check 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 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.
• As needed, mentor new or less experienced team members on regulatory submissions or safety label update evaluation.
• Provide technical and administrative support to Global Labeling Managers and Head of Global Labeling.

WHAT YOU’LL BRING TO THE ROLE:

Essential Requirements:

• Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) - Masters or Bachelors.
• Good written and spoken English. Local language is an advantage.
• 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.
• Experience in managing databases; creating and maintaining share points; with added skills in Excel, is preferred.
• Exposure towards project management is a plus.
• Well-structured, result-oriented, highly self-committed, resilient, flexible, team player.
• High operational excellence orientation.