Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

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 and participates in negotiations on later stage products with regulatory agencies on approval of label. Monitors, evaluates and recommends improvements to labeling processes, quality, systems tools and/or policies.

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Review and assess local country labels to identify deviations from the core labeling and propose topics for further cross-functional assessment during the periodic core labeling review process
• Contribute to DRA activities regarding Sandoz safety risk communications/portfolio stewardship activities having labeling impact for their assigned projects/products.
• Contribute to the creation of high quality documents supporting changes with internal and/or external experts including the preparation of responses to labeling related Health Authority queries
• Ensure that key country label proposals which deviate from a proposed CDS or CDS amendment/update (e.g., US PI, EU SmPC) are brought to the attention -A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
• Networks with senior internal and external personnel in own area of expertise.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

 

What you’ll bring to the role:

Essential Requirements:

• Cross Cultural Experience.
• People Challenges.
• Functional Breadth.
• Project Management.
• Collaborating across boundaries.
   

 Skills:

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

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!

Skills Desired

Cross-Functional Teams, Detail-Oriented, Labeling Documentation, Labeling Regulations, Operational Excellence, Regulatory Compliance, Safety