Global Labelling Lead

ph3Company Description /h3 pAt 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. /p h3Benefits /h3 ul liCompetitive compensation for your work /li liEmphasis on work/life balance /li liCollaborative and team-oriented environment /li liOpportunities for professional growth /li liDiversity and Inclusion /li liMaking a positive impact to help ultra-rare disease patients who are in need of life‑saving treatments /li /ul h3Job Description /h3 pThe 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. /p pThe 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. /p ul liLead the content development, approval, and maintenance of the Company Core Data Sheet (CCDS) and US/EU Product Information (PI). /li liManage the review and approval of country labeling for new filings in international markets. /li liEnsure compliance with relevant Health Authority (HA) regulations, internal procedures, and business objectives. /li liSupport continuous improvement of labeling processes and systems. /li /ul h3Key Responsibilities /h3 ul liLead 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). /li liGuide LWGs in

labeling discussions with HAs, 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. /li liPresent new labeling content and major updates to the Executive Labeling Committee for approval. /li liPartner with international Regulatory Affairs (RA) to guide the review and approval process of labels for submission outside of EU and US. /li liMaintain oversight of labeling compliance, including documentation of labeling content deviations and end‑to‑end tracking of safety variations. /li liContribute to the development and improvement of labeling processes, including creation and review of process documents. /li liSupport inspections and audits related to labeling activities. /li liParticipate in cross‑functional and cross‑regional initiatives to strengthen collaboration and increase operational efficiencies. /li /ul h3Qualifications /h3 ul liDegree (Bachelors, Masters, State Examination, Diploma), preferably in a scientific

discipline such as Pharmacy, Medicine, Life or Natural Sciences. /li liAt 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. /li liExperience 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. /li liExperience leading project teams in a cross‑functional matrix environment. /li liComfortable working in a global, cross‑functional environment, collaborating effectively with stakeholders across multiple regions, time zones, and cultural backgrounds. /li liExperience with Regulatory Information Management systems. /li liStrong proficiency with standard business tools (e.g., MS‑Office). /li

liExcellent English language skills (oral/written/listening); additional languages are an advantage. /li liAbility to plan, coordinate and lead multiple projects concurrently. /li /ul h3Desired /h3 ul liKnowledge of labeling requirements and templates in geographic regions outside of the US and EU. /li liExperience in aligned drug and device processes related to Instructions for Use (IFU) management. /li /ul /p