Regulatory Affairs Manager – Permanent Role

vor 1 Woche

Zug, Schweiz AurigaVision AG Vollzeit

Our client is an established, innovation-focused pharmaceutical company with a strong presence in the Swiss market. The organization operates internationally and is active in several therapeutic areas with a clear commitment to high-quality regulatory standards. For their Swiss affiliate, we are currently seeking aRegulatory Affairs Manager (Ref) – Permanent RoleZurich / Fluency in GermanIn this role, you will be responsible for managing regulatory activities for assigned medicinal products in Switzerland, including new market authorizations and lifecycle management. You will collaborate closely with Swissmedic as well as European and global Regulatory Affairs teams. Cross-functional cooperation with departments such as Medical, Quality, Supply Chain, and Commercial will be part of your daily work.Your main tasksServe as the primary regulatory contact for Swissmedic for assigned productsPrepare and manage regulatory submissions for new marketing authorisations and lifecycle changesDevelop and implement regulatory strategies for Switzerland in coordination with international teamsEnsure compliance with national and international regulatory requirementsMaintain product licences, including variations, renewals, and safety submissionsProvide regulatory support for product launches and supply-related topicsMonitor regulatory developments and inform internal stakeholders accordinglyYour profileSolid knowledge of Swiss regulatory requirements and Swissmedic proceduresAt least 5 years of professional experience in Regulatory Affairs within the pharmaceutical industry (ideally Specialty Care/Oncology)Focus on pre-submission and post-approval activitiesUniversity degree in Pharmacy, Medicine, Life Sciences, or a related disciplineExperience with marketing authorisation applications and lifecycle managementStrong communication and stakeholder management skillsStructured, independent, and reliable working styleFluency in German and English; additional languages are an advantageDomagoj Odrljin is looking forward to receiving your application documents via our job portal (CV, diploma, reference letters; no motivational letter necessary).Full discretion is guaranteed and we will gladly answer any additional questions. jid140754ca jit0104a jiy26a

  • Regulatory Affairs Manager – Permanent Role

    vor 1 Woche

    Zug, Schweiz AurigaVision AG Vollzeit

    Our client is an established, innovation-focused pharmaceutical company with a strong presence in the Swiss market. The organization operates internationally and is active in several therapeutic areas with a clear commitment to high-quality regulatory standards. For their Swiss affiliate, we are currently seeking aRegulatory Affairs Manager (Ref) –...

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