Global Labelling Lead

Sobi - Swedish Orphan Biovitrum AB (publ)

Global Labeling Lead providing strategic and operational leadership for Sobi products in Regulatory Affairs. Ensuring compliance and improving labeling processes within global markets.

Posted 7/15/2026full-timeRemote • 🇬🇧 United KingdomSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs and labeling strategy, with a strong focus on compliance with Health Authority regulations and effective collaboration in cross-functional teams. Proficient in managing labeling processes and documentation for pharmaceutical products throughout their lifecycle.

Highest-signal resume keywords

Regulatory Affairs ExperiencePrescription Drug LabelingLabeling Compliance OversightCross-Functional Team LeadershipRegulatory Information Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Labeling Strategy DevelopmentCore Data Sheet ManagementUS Prescribing InformationEU Prescribing InformationTarget Product LabelingProject ManagementLabeling Document ReviewPharmaceutical RegulationsContinuous Improvement ProcessesSafety Variation Tracking

Soft Skills

Effective CollaborationCultural SensitivityProject CoordinationCommunication SkillsLeadership

Tools & Technologies

Regulatory Information Management SystemsMS-Office

Industry Keywords

Pharmaceutical IndustryHealth Authority RegulationsGlobal Regulatory AffairsLabeling Working GroupsCross-Functional Environment

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).
The GLL provides both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders.
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).
Document and archive LWG decisions and outcomes.
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.

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