Global Labelling Lead

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

📋 Description

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

• Provide strategic and operational guidance for product labeling while collaborating closely with Regulatory Strategy Leads and various cross-functional stakeholders.

• Oversee the development, approval, and upkeep of the Company Core Data Sheet (CCDS) and US/EU Product Information (PI).

• Manage the evaluation and authorization of country-specific labeling for new submissions in international markets.

• Ensure adherence to pertinent Health Authority (HA) regulations, internal protocols, and business objectives.

• Facilitate ongoing enhancements of labeling processes and systems.

• Direct the development, execution, and maintenance of the CCDS, USPI, and EU PI for assigned Sobi products throughout their lifecycle via cross-functional Labeling Working Groups (LWG).

• Guide LWGs in discussions with HAs regarding labeling while ensuring alignment with management and compliance with labeling governance.

• Collaborate effectively with internal stakeholders and partner organizations, as necessary.

• Document and archive decisions and outcomes from LWG meetings.

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

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

• Maintain oversight of labeling compliance, including documentation of content deviations and comprehensive tracking of safety variations.

• Contribute to the enhancement of labeling processes, including the creation and review of process documentation.

• Assist in inspections and audits related to labeling activities.

• Participate in cross-functional and cross-regional initiatives to enhance collaboration and boost operational efficiencies.

⛳️ Requirements

• A degree (Bachelors, Masters, State Examination, Diploma) in a scientific discipline such as Pharmacy, Medicine, Life Sciences, or Natural Sciences is preferred.

• A minimum of 5 years of experience in Regulatory Affairs within the pharmaceutical sector or a regulatory authority, including at least 3 years 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 marketed and investigational products.

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

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

• Experience with Regulatory Information Management systems.

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

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

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

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

• Experience with aligned drug and device processes concerning Instructions for Use (IFU) management.

🏝️ Benefits

• Competitive compensation for your contributions.

• Focus on maintaining a work/life balance.

• A collaborative and team-oriented workplace.

• Opportunities for professional development and growth.

• Commitment to Diversity and Inclusion.

• Contribute positively to assist patients with ultra-rare diseases who require life-saving treatments.