Senior Global Labeling Manager (m/w/d) – Pharmaceutical Regulatory Affairs
Shape the Future of Global Drug Labeling – Your Expertise Matters!
* Duration: 01.02.2026 – 31.07.2026
* Location: Basel
* Employment Type: Temporary Assignment
* Hourly Rate: CHF 54.00/h to CHF 73.00/h
About Our Client
For our client, a renowned pharmaceutical enterprise in the Basel region, we are seeking an experienced Senior Global Labeling Manager (m/w/d). This innovative organization operates at the forefront of drug development and regulatory excellence, committed to delivering transformative therapies to patients across international markets. With a strong focus on scientific advancement and regulatory compliance, the company plays a leading role in shaping global healthcare standards.
Your Responsibilities
* Act as the primary point of contact for all labeling-related matters and drive labeling excellence across assigned product portfolios
* Develop, update, and maintain regulatory-compliant global labeling documents, including Core Data Sheets (CDS), Basic Patient Leaflets (BPL), and Basic Succinct Statements (BSS)
* Lead Expert Labeling Task Forces (ELTF) to establish labeling strategies, facilitate cross-functional alignment, and achieve consensus on labeling content
* Serve as a core member of Regulatory Affairs Sub-teams and Safety Management Teams (SMTs) for designated projects and products
* Conduct in-depth research on labeling topics by analyzing international labels, competitor documentation, clinical study data, and regulatory frameworks
* Prepare high-quality regulatory submissions supporting CDS modifications and responses to Health Authority inquiries
* Collaborate with Country Organizations to ensure timely and consistent implementation of global labeling updates in local product information
* Support Regulatory Affairs activities related to safety risk communications and portfolio stewardship initiatives with labeling implications
* Present labeling strategies and updates to relevant boards, forums, and committees (e.g., MSRB, PSB)
* Prepare and review Periodic Safety Update Report (PSUR) regulatory input for assigned products
* Review and approve International Package Leaflets to ensure regulatory compliance and quality standards
* Provide mentorship and guidance to junior team members and new Global Labeling Managers
* Contribute to continuous improvement initiatives within global labeling management processes
* Evaluate and provide input on emerging internal and external regulatory guidelines affecting labeling practices
* Represent the Global Labeling function during audits and regulatory inspections
Your Profile
* Academic background: Bachelor's or Master's degree in life sciences; advanced degree (MD, PhD, PharmD) is highly desirable
* Professional experience: Minimum 4-6 years of specialized experience in global pharmaceutical labeling, or 5+ years in related pharmaceutical industry roles or Health Authority positions
* Fluent in English as business language; additional language skills are advantageous
* Strong interpersonal and communication skills with the ability to influence and negotiate effectively
* Proven ability to lead cross-functional teams and manage projects in a matrix organization
* Excellent organizational awareness and understanding of business priorities and departmental interdependencies
* Solid knowledge of medical and scientific terminology and drug safety information
* Demonstrated problem-solving capabilities and strategic thinking skills
What We Offer – Your Benefits with nemensis AG
* nemensis AG is your specialized personnel partner in the Life Sciences sector, based in Basel
* Comprehensive consultation and support throughout the entire application process by our experienced Consultants
* Access to an extensive client network and exciting opportunities in Northwestern Switzerland
* Quick and straightforward onboarding through individual guidance and personalized support during the recruitment process
Ready for Your Next Career Move?
At nemensis AG, we've already connected thousands of professionals with their dream jobs, giving them the opportunity to develop further or re-enter the job market. What can we do for you and your career today? Get in touch with us!
Branche: Pharma-Industrie
Funktion: Qualitätsprüfung
Anstellungsart: Befristeter Vertrag