Global Labelling Lead

This is a fully remote position, open to applicants in France.

📋 Description

• The Global Labeling Lead (GLL) acts as an expert in labeling strategy for Sobi products within Global Regulatory Affairs (GRA).

• Provides both strategic direction and operational leadership for product labeling, collaborating closely with Regulatory Strategy Leads and various cross-functional stakeholders.

• Ensures that product labeling demonstrates scientific integrity, regulatory compliance, and a focus on patients across global markets.

• Directs the development, approval, and maintenance of the Company Core Data Sheet (CCDS) as well as US/EU Product Information (PI).

• Oversees the review and approval of country-specific labeling for new submissions in international markets.

• Guarantees compliance with applicable Health Authority (HA) regulations, internal procedures, and business objectives.

• Promotes continuous enhancement of labeling processes and systems.

• Guides Label Working Groups (LWGs) in discussions with HAs, ensuring management alignment and adherence to labeling governance.

• Documents and archives decisions and outcomes from LWGs.

• Presents new labeling content and significant updates to the Executive Labeling Committee for approval.

• Collaborates with international Regulatory Affairs (RA) to steer the review and approval process of labels for submissions outside the EU and US.

• Maintains oversight of labeling compliance, including documenting deviations in labeling content and tracking safety variations from start to finish.

• Aids in the development and refinement of labeling processes, including the creation and review of process documentation.

• Supports inspections and audits related to labeling activities.

• Engages in cross-functional and cross-regional initiatives to enhance collaboration and improve operational efficiencies.

⛳️ Requirements

• A degree (Bachelor's, Master's, State Examination, Diploma), preferably in a scientific field such as Pharmacy, Medicine, Life or Natural Sciences.

• A minimum of 5 years of experience in Regulatory Affairs within the pharmaceutical industry or a regulatory authority, with at least 3 years of relevant experience in prescription drug labeling.

• Familiarity with various 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.

• Proven experience in leading project teams within a cross-functional matrix environment.

• Comfortable operating in a global, cross-functional setting, effectively collaborating with stakeholders across different regions, time zones, and cultural backgrounds.

• Experience with Regulatory Information Management systems.

• Strong proficiency in standard business tools (e.g., MS Office, etc.).

• Excellent command of the English language (oral/written/listening); proficiency in additional languages is a plus.

• Capability to plan, coordinate, and manage multiple projects simultaneously.

• Preferred: Knowledge of labeling requirements and templates in regions outside the US and EU.

• Experience in aligned drug and device processes related to Instructions for Use (IFU) management.

🏝️ Benefits

• Competitive compensation for your contributions.

• Focus on work/life balance.

• A collaborative and team-oriented work environment.

• Opportunities for professional development.

• Commitment to Diversity and Inclusion.

• The chance to make a meaningful impact by helping patients with ultra-rare diseases who require life-saving treatments.