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 skilled 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
📌 Global Labelling Manager (India)
🏢 Sandoz
📍 India