Global Labelling Lead
Job in
4040, Basel, Kanton Basel-Landschaft, Switzerland
Listing for:
Doist
Full Time
position
Listed on 2026-07-23
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, AI Business & Operations
-
Pharmaceutical
Regulatory Compliance Specialist, AI Business & Operations
Salary/Wage Range or Industry Benchmark: 120000 - 180000 CHF Yearly
CHF
120000.00
180000.00
YEAR
Job Description & How to Apply Below
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 on 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, internal procedures, and business objectives. Support continuous improvement of labeling processes and systems.
Key Responsibilities Lead the development, implementation, and maintenance of the CCDS, USPI and EU PI for assigned Sobi products throughout the product lifecycle via cross‑functional Labeling Working Groups (LWG).Guide LWGs in labeling discussions with HAs, while ensuring management alignment and adherence to labeling governance.Collaborate closely with internal stakeholders and partner companies, as applicable, and document and archive LWG decisions and outcomes.Present new labeling content and major updates to the Executive Labeling Committee for approval.Partner with international Regulatory Affairs (RA) to guide the review and approval process of labels for submission outside of EU and US.Maintain oversight of labeling compliance, including documentation of labeling content deviations and end‑to‑end tracking of safety variations.Contribute to the development and improvement of labeling processes, including creation and review of process documents.Support inspections and audits related to labeling activities.Participate in cross‑functional and cross‑regional initiatives to strengthen collaboration and increase operational efficiencies.#J-18808-Ljbffr
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