Global Labelling Lead

Sobi - Swedish Orphan Biovitrum AB (publ)

Global Labeling Lead managing labeling strategy for Sobi products in Global Regulatory Affairs. Collaborating across teams to ensure compliance and scientific integrity in labeling across markets.

Posted 7/15/2026full-timeRemote • 🇵🇱 PolandSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs and product labeling, ensuring compliance with Health Authority regulations and maintaining scientific integrity across global markets. Proven ability to lead cross-functional teams and manage multiple projects in a dynamic, international environment.

Highest-signal resume keywords

Regulatory Affairs ExperiencePrescription Drug LabelingCore Data Sheet DevelopmentProject LeadershipRegulatory Information Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceLabeling StrategyLabeling Document ReviewContent DevelopmentLabeling Governance

Soft Skills

CollaborationCommunicationLeadershipProject CoordinationCultural Sensitivity

Tools & Technologies

MS-OfficeRegulatory Information Management Systems

Industry Keywords

Pharmaceutical IndustryHealth Authority RegulationsCore Data SheetPrescribing InformationLabeling Working Groups

About the role

Key responsibilities & impact

The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA)
Provides both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders
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
Guide Labeling Working Groups (LWG) in labeling discussions with HAs, while ensuring management alignment and adherence to labeling governance
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