Manager Regulatory & Quality Affairs (m/f/d)📍 Location: Zug | 🕒 Workload: 80-100% | 🏢 Industry: Pharmaceuticals / Life Sciences | 📅 Start Date: asap | 💼 Contract Type: PermanentAbout the RoleIn this key position, you will manage the preparation, submission, and maintenance of marketing authorisation dossiers for medicinal products in Switzerland. Acting as the main contact for Swissmedic, suppliers, and strategic partners, you ensure full regulatory compliance. AsQualified Person / Responsable Technique, you will take responsibility for GDP-compliant processes, batch release, and quality management.ResponsibilitiesPrepare and maintain regulatory dossiers (MAAs, variations, renewals)Coordinate with internal departments and external partnersAct as Qualified Person / Responsable Technique under Swiss lawEnsure GDP/GMP compliance and oversee the QMSApprove batch releases and support audits/inspectionsMaintain SOPs, quality agreements, and regulatory databasesMonitor regulatory changes and update processes accordinglyLead preparation and follow-up for Swissmedic inspectionsSupport CAPA management, deviation handling, and change control processesProfileDegree in Life Sciences/Pharmacy or equivalentSeveral years' experience in Regulatory Affairs and Quality Assurance (GDP/GMP)Strong knowledge of Swissmedic requirements and eCTD submissionsExperience as Qualified Person / Responsable TechniqueStrong project management and cross-functional collaboration skillsExcellent written and verbal communication in English (German an asset)Independent, structured working style with high attention to detailNice to HaveExperience with EU or global regulatory submissionsKnowledge of Pharmacovigilance / Drug SafetyFamiliarity with international GDP/GMP standardsBenefitsA dynamic and collaborative work environment within the life sciences industryExciting projects with a high level of autonomy and responsibilityOpportunities for continuous learning and professional developmentCompetitive compensation and benefits packageFlexible working arrangements to support work-life balanceThe chance to make a meaningful impact on the quality and safety of medicinal products in SwitzerlandContact informationIn case of any questions on this vacancy (ref.: JN -082025-831797), please contact Marcel Nürnberg at +41 58 233 44 80 .About UsAdecco is the market leader for staffing solutions in Switzerland and worldwide. Every day, our teams in our 50 locations throughout Switzerland ensure the best match between candidates and clients in various professional fields and industries. Adecco Switzerland is part of the Adecco Group, the world's leading talent advisory and solutions company. We believe in making the future work for everyone, and every day enable more than 3.5 million careers. We skill, develop, and hire talent in 60 countries, enabling organisations to embrace the future of work.Ref:
