Senior Regulatory Affairs Manager - Global Labeling (m/f/d) 100%

nemensis ag

Senior Global Labeling Manager (m/w/d) – Pharmaceutical Regulatory AffairsShape 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/hAbout Our ClientFor 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 ResponsibilitiesAct as theprimary point of contactfor all labeling-related matters and drive labeling excellence across assigned product portfoliosDevelop, update, and maintainregulatory-compliant global labeling documents, including Core Data Sheets (CDS), Basic Patient Leaflets (BPL), and Basic Succinct Statements (BSS)LeadExpert Labeling Task Forces (ELTF)to establish labeling strategies, facilitate cross-functional alignment, and achieve consensus on labeling contentServe as acore memberof 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 frameworksPreparehigh-quality regulatory submissionssupporting CDS modifications and responses to Health Authority inquiriesCollaborate with Country Organizations to ensuretimely and consistent implementationof global labeling updates in local product informationSupport Regulatory Affairs activities related tosafety risk communicationsand portfolio stewardship initiatives with labeling implicationsPresent labeling strategies and updates to relevant boards, forums, and committees (e.g., MSRB, PSB)Prepare and reviewPeriodic Safety Update Report (PSUR)regulatory input for assigned productsReview and approveInternational Package Leafletsto ensure regulatory compliance and quality standardsProvidementorship and guidanceto junior team members and new Global Labeling ManagersContribute tocontinuous improvement initiativeswithin global labeling management processesEvaluate and provide input on emerginginternal and external regulatory guidelinesaffecting labeling practicesRepresent the Global Labeling function duringaudits and regulatory inspectionsYour ProfileAcademic background:Bachelor's or Master's degree in life sciences; advanced degree (MD, PhD, PharmD) is highly desirableProfessional experience:Minimum4-6 years of specialized experiencein global pharmaceutical labeling, or5+ yearsin related pharmaceutical industry roles or Health Authority positionsFluent in Englishas business language; additional language skills are advantageousStronginterpersonal and communication skillswith the ability to influence and negotiate effectivelyProven ability tolead cross-functional teamsand manage projects in a matrix organizationExcellentorganizational awarenessand understanding of business priorities and departmental interdependenciesSolid knowledge ofmedical and scientific terminologyand drug safety informationDemonstratedproblem-solving capabilitiesand strategic thinking skillsWhat We Offer – Your Benefits with nemensis AGnemensis AGis your specialized personnel partner in the Life Sciences sector, based in BaselComprehensiveconsultation and supportthroughout the entire application process by our experienced ConsultantsAccess to anextensive client networkand exciting opportunities in Northwestern SwitzerlandQuick and straightforward onboardingthrough individual guidance and personalized support during the recruitment processReady 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!?Phill Rogers, Consultant,Phillip.Rogers@nemensis.comYou're looking for a change of perspective, but this isn't the right position for you? Then register with us – we'll contact you for an initial meeting to understand your wishes and needs and align ourselves accordingly.