Specialist Global Labeling (m/f/d)

Job Description Summary

The Specialist Global Labeling is a member of the global labeling team within Sandoz Regulatory Affairs, who is responsible for maintaining up-to-date and compliant core labeling documents for assigned products throughout their lifecycle. The Specialist Global Labeling also assists in improving process efficiencies for CDS updates, evaluating information from health authority and reference product websites, and supporting compliance tasks, audits, and inspections.

Job Description

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!

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.

You’ll receive:

Sandoz has an employee-first approach and that’s why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200,000 learning videos and 5000+ courses.

In addition to the various learning opportunities, we offer company benefits, such as:

• 30 days of annual leave
• Holiday allowance
• Additional rewards for special occasions (e.g. service length awards, marriage celebration, etc.)
• Company pension schemes and capital formation benefits
• Parental leave
• Other offerings, such as bike leasing

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art 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 and entrepreneurial spirit 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 encouraged! 

The future is ours to shape!

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Sandoz Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Sandoz and our career opportunities, join the Sandoz Network here: https://talentnetwork.novartis.com/sandoztalentpool

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Skills Desired

Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance