Headquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals
Global Labelling Lead
Location
Switzerland
Posted
5 days ago
Salary
0
Seniority
Senior
Job Description
Global Labelling Lead
Sobi - Swedish Orphan Biovitrum AB
• 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. • 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. • Participate in cross-functional and cross-regional initiatives to strengthen collaboration and increase operational efficiencies.
Job Requirements
- Degree (Bachelors, Masters, State Examination, Diploma), preferably in a scientific discipline such as Pharmacy, Medicine, Life or Natural Sciences.
- At least 5 years of experience in Regulatory Affairs within the pharmaceutical industry or a regulatory authority, including at least 3 years of relevant experience in prescription drug labeling.
- Experience working with different types of labeling documents, including (Development) Core Data Sheets, EU and/ or US Prescribing Information, and Target Product Labels, for both marketed and investigational products.
- Experience leading project teams in a cross-functional matrix environment.
- Comfortable working in a global, cross-functional environment, collaborating effectively with stakeholders across multiple regions, time zones and cultural backgrounds.
- Experience with Regulatory Information Management systems.
- Strong proficiency with standard business tools (e.g. MS-Office, etc.)
- Excellent English language skills (oral/written/listening); additional languages are an advantage.
- Ability to plan, coordinate and lead multiple projects concurrently.
Benefits
- Competitive compensation for your work
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
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