Global Labelling Lead

Job description

Global Labelling Lead Munich, BY, Germany Science Full-time Company Description At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team: 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 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, internal procedures, and business objectives. Support continuous

improvement of labeling processes and systems. 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. Participate in cross-functional and cross-regional initiatives to strengthen collaboration and increase operational efficiencies. Qualifications 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. Additional Information