Expert in Drug Quality and Regulation Switzerland

Expert in Drug Quality and Regulation (Pre & PostMarket) Switzerland At Fresenius Medical Care, we are globally leading in renal care and are committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care throughout the entire healthcare journey. Guided by our vision "Creating a livable future. For patients. Worldwide. Every day." – we work with determination and compassion, supported by a global team of over 125,000 employees. In the Care Enablement segment, we develop and offer life-sustaining medical products, digital health solutions, and therapies that strengthen clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Our values determine how we work: We care for our patients, each other, and our communities We connect teams and borders to achieve excellence together We commit to doing things right – growing with determination and leading renal care with integrity and innovation. Responsible for regulatory affairs, BIP, and pharmacovigilance Switzerland (m/w/d) D/E Your tasks as: Expert for drug quality and regulation (Pre & PostMarket) – Switzerland: In this key role, you ensure that our medicines comply with regulations (Swissmedic) throughout their entire lifecycle – from approval to market surveillance and distribution. You will act as a central expert for regulatory questions, BIP/BIP, and pharmacovigilance and make a significant contribution to patient safety and market access. Responsibility for regulatory topics in Switzerland (and partially in Austria) Contact person for authorities (especially Swissmedic) and internal stakeholders Monitoring of registrations, variations, and product maintenance Ensuring BIP/BIP compliance in the supply chain (including logistics partners like Galliker) Monitoring and co-shaping pharmacovigilance activities Support during audits, inspections, and regulatory changes Participation in quality and improvement initiatives Your profile: Scientific background, Bachelor's/Master's degree or similar and comparable education: Pharmacy, chemistry, biology, life sciences Or pharmacist Experience in regulatory affairs, quality, or pharmacovigilance Knowledge of legal requirements, experience with Swissmedic I already live in Central Switzerland or am willing to relocate Pharmacist training is not a must, FvP training is a plus German and English are required for negotiation Our offer for you: A responsible role with direct impact on patient safety Combination of international environment and strong local responsibility Flexible working (hybrid model) Development opportunities – FvP responsibility A large number of committed people with a broad spectrum of skills, talents, and experiences Have we sparked your interest? If you are interested in a responsible and diverse area of responsibility, we look forward to your detailed application. CONTACT ADDRESS Fresenius Medical Care (Schweiz) AG. Frau Ercolani, Aawasserstraße 2, 6370 Oberdorf/NW jid77ab124jm jit0522jm jiy26jm