Global Labelling Lead

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Sobi - Swedish Orphan Biovitrum AB (publ)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1991

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions.

📋 Description

• The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA). • Provide both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders. • 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. • 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. • Participate in cross-functional and cross-regional initiatives to strengthen collaboration and increase operational efficiencies.

🎯 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. • Desired: Knowledge of labeling requirements and templates in geographic regions outside of the US and EU. • Experience in aligned drug and device processes related to Instructions for Use (IFU) management.

🏖️ 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