Senior Global Labeling Manager (m/w/d)

We are looking for an experienced Senior Global Labeling Manager (m/w/d) to work with our customer, a renowned pharmaceutical company in Basel.

Responsibilities

• Lead all labeling-related activities and ensure compliance with regulatory standards
• Maintain up-to-date global labeling documents, including Core Data Sheets (CDS), Basic Patient Leaflets (BPL), and Basic Succinct Statements (BSS) for assigned products
• Present proposed CDS changes to the Global Labelling Committee (GLC)
• Organize and lead the Expert Labelling Task Force (ELTF) to define labeling strategies and finalize labeling texts
• Represent Global Labelling (GL) in Regulatory Affairs (RA) Sub-teams and Safety Management Teams (SMTs)
• Conduct research on labeling topics, including competitor labels, regulatory requirements, and market-specific variations
• Develop high-quality documents supporting CDS updates and responses to health authority inquiries
• Collaborate with country organizations (COs) to ensure timely and compliant implementation of global labeling changes
• Support regulatory activities related to safety risk communications and portfolio stewardship
• Lead or contribute to labeling-related presentations at key committees and forums
• Review and approve International Package Leaflets and regulatory input for Periodic Safety Update Reports (PSURs)
• Mentor and support junior Global Labelling Managers
• Contribute to continuous improvement initiatives and review emerging regulatory guidelines
• Represent GL in audits and inspections to ensure compliance and best practices
• Tenure period : 01/04/2025 to 31/08/2025

Requirements

• Education: A science-based BS or MS with relevant experience; an advanced degree (MD, PhD, PharmD) is preferred
• Languages: Fluency in English is required, with additional languages being advantageous
• Experience: Demonstrated expertise and seniority in global labeling activities
• Possess extensive experience of at least 4–6 years in global labeling, or over 5 years in related pharmaceutical areas or Health Authorities
• Strong interpersonal, project management, communication, negotiation, and problem-solving skills
• Proven ability to lead cross-functional teams in a matrix environment
• High organizational awareness with a clear understanding of interdepartmental relationships and business priorities
• Sound understanding of medical and scientific terminologies
• A good grasp of drug safety information

Benefits

• 5 weeks holiday / 40h week
• Assumption of certification costs
• Reka-Card with a 20% discount on up to CHF 2,400
• Up to CHF 400 contribution to fitness subscription