Global Labelling Lead — Sobi
NewCHF 85'500 - 129'500
Sobi · Basel (BS)
- Location
- Basel
- Contract
- full-time
- Posted
- 2 days ago
SalaryCHF 85'500 - 129'500
Role overview
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.
- 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.
- Key responsibilities will include:
- 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).
- Degree (Bachelors, Masters, State Examination, Diploma), preferably in a scientific discipline such as Pharmacy, Medicine, Life or Natural Sciences.
Main responsibilities
- Key responsibilities will include:
- 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.
- 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.
Key requirements
- Degree (Bachelors, Masters, State Examination, Diploma), preferably in a scientific discipline such as Pharmacy, Medicine, Life or Natural Sciences.
Additional details
- Ability to plan, coordinate and lead multiple projects concurrently.
