Global Labelling Lead

Sobi - Swedish Orphan Biovitrum AB (publ)

Global Labeling Lead managing labeling strategy for Sobi products in compliance with regulations and patient focus. Collaborates with cross-functional teams to ensure product labeling integrity and compliance.

Posted 7/15/2026full-timeRemote • 🇨🇭 SwitzerlandSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs with a focus on prescription drug labeling, ensuring compliance with Health Authority regulations and effective collaboration across global teams. Proficient in managing labeling processes and documentation while leading cross-functional initiatives to enhance operational efficiencies.

Highest-signal resume keywords

Regulatory Affairs ExperiencePrescription Drug LabelingCore Data Sheet DevelopmentRegulatory Information Management SystemsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsPrescription Drug LabelingCore Data Sheet DevelopmentLabeling ComplianceLabeling DocumentationProcess ImprovementProject ManagementLabeling GovernanceCross-Functional CollaborationAudit Support

Soft Skills

Effective CommunicationStakeholder CollaborationCultural SensitivityLeadershipPlanning and Coordination

Tools & Technologies

Regulatory Information Management SystemsMS Office

Industry Keywords

Health Authority RegulationsPharmaceutical IndustryInternational MarketsLabeling ProcessesCross-Regional Initiatives

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Comp & perks

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