Senior Regulatory Affairs Manager

Senior Global Labeling Manager (m/w/d) – Pharmaceutical Regulatory Affairs Shape the Future of Global Drug Labeling – Your Expertise Matters Duration: 01.02.2026 – 31.07.2026Location: BaselEmployment Type: Temporary AssignmentHourly 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 portfoliosDevelop, 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 contentServe as a core member of Regulatory Affairs Sub-teams and Safety Management Teams (SMTs) for designated projects and productsConduct in-depth research on labeling topics by analyzing international labels, competitor documentation, clinical study data, and regulatory frameworksPrepare high-quality regulatory submissions supporting CDS modifications and responses to Health Authority inquiriesCollaborate with Country Organizations to ensure timely and consistent implementation of global labeling updates in local product informationSupport Regulatory Affairs activities related to safety risk communications and portfolio stewardship initiatives with labeling implicationsPresent 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 productsReview and approve International Package Leaflets to ensure regulatory compliance and quality standardsProvide mentorship and guidance to junior team members and new Global Labeling ManagersContribute to continuous improvement initiatives within global labeling management processesEvaluate and provide input on emerging internal and external regulatory guidelines affecting labeling practicesRepresent 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 desirableProfessional experience: Minimum 4-6 years of specialized experience in global pharmaceutical labeling, or 5+ years in related pharmaceutical industry roles or Health Authority positionsFluent in English as business language; additional language skills are advantageousStrong interpersonal and communication skills with the ability to influence and negotiate effectivelyProven ability to lead cross-functional teams and manage projects in a matrix organizationExcellent organizational awareness and understanding of business priorities and departmental interdependenciesSolid knowledge of medical and scientific terminology and drug safety informationDemonstrated 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 BaselComprehensive consultation and support throughout the entire application process by our experienced ConsultantsAccess to an extensive client network and exciting opportunities in Northwestern SwitzerlandQuick 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-IndustrieFunktion: QualitätsprüfungAnstellungsart: Befristeter Vertrag