Global Labelling Lead

Sobi seeks a Global Labelling Lead in Basel to drive labeling strategy and compliance for its pharmaceutical products, ensuring scientific integrity and regulatory adherence across global markets.

This position acts as the central expert for labeling strategy within Sobi’s Global Regulatory Affairs team. The role is responsible for providing both strategic direction and operational management of product labeling, ensuring that all documentation maintains scientific accuracy, meets regulatory standards, and keeps patient needs at the forefront.

Responsibilities

• Oversee the creation, approval, and ongoing maintenance of the Company Core Data Sheet (CCDS) as well as US and EU Product Information.
• Direct the review and approval processes for country-specific labeling for new filings in international markets.
• Ensure all labeling activities comply with Health Authority regulations, internal protocols, and business goals.
• Lead the Labeling Working Groups to develop and maintain CCDS, USPI, and EU PI throughout the product lifecycle.
• Guide these working groups during discussions with Health Authorities, ensuring alignment with management and governance standards.
• Present new labeling content and significant updates to the Executive Labeling Committee for final approval.
• Collaborate with international Regulatory Affairs teams to manage the review and approval of labels for submissions outside the EU and US.
• Monitor labeling compliance, including tracking safety variations and documenting any deviations in labeling content.
• Contribute to the refinement of labeling processes and the creation or review of related process documents.
• Provide support during inspections and audits concerning labeling activities.
• Participate in cross-functional and cross-regional projects to enhance collaboration and operational efficiency.

Requirements

• A university degree in a scientific field such as Pharmacy, Medicine, or Life Sciences.
• Minimum of five years of experience in Regulatory Affairs within the pharmaceutical sector or a regulatory body.
• At least three years of specific experience in prescription drug labeling.
• Proven experience handling various labeling documents, including Core Data Sheets, EU/US Prescribing Information, and Target Product Labels for both marketed and investigational products.
• Demonstrated ability to lead project teams within a cross-functional matrix structure.
• Strong capability to work effectively in a global environment, collaborating with stakeholders across different regions, time zones, and cultures.
• Familiarity with Regulatory Information Management systems.
• High proficiency in standard business tools, particularly MS-Office.
• Excellent command of the English language, both written and spoken.
• Ability to plan, coordinate, and lead multiple projects simultaneously.

Nice to have

• Knowledge of labeling requirements and templates in regions outside the US and EU.
• Experience with aligned drug and device processes, specifically regarding Instructions for Use (IFU) management.
• Proficiency in additional languages.

What the company offers

• Competitive salary package.
• A strong emphasis on maintaining a healthy work-life balance.
• A collaborative and team-oriented workplace culture.
• Clear opportunities for professional development and growth.
• A commitment to Diversity and Inclusion.
• The chance to make a meaningful impact by supporting patients with ultra-rare diseases who require life-saving treatments.

About the company

Sobi is dedicated to developing and delivering innovative therapies to improve the lives of people living with rare diseases. The company believes its strength lies in its team of diverse individuals who bring their unique talents to work together, driven by a deep commitment to patients.

• Each employee contributes their unique skills to the team to create a positive difference.
• The company focuses on creating innovative treatments for rare disease patients.
• Success is driven by the team's collective talent and dedication to patient care.