Vacancy Description
Job Description
The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA).
This role can be located in several countries in Europe and Switzerland, depending where the chosen candidate will be located.
The GLL provides both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders. As a core member of the Global Regulatory Team(s) (GRT) for assigned product(s), the GLL ensures that product labeling reflects scientific integrity, regulatory compliance, and patient focus across global markets:
- Lead the content development, approval, and maintenance of the Company Core Data Sheet (CCDS) and US/EU Product Information (PI).
- Manage the review and approval of country labeling for new filings in international markets.
- Ensure compliance with relevant Health Authority (HA) regulations, i...
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