Reg Affairs Specialist; Documentation

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• 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.

What you’ll bring to the role:

Essential Requirements:

• At least 5 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 sharepoints; 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

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!