Stellenangebote für: - CMC REGULATORY
1 bis 6 von 6 Angebote für CMC REGULATORYSenior Expert Regulatory Affairs - CMC/Biosimilars
Shape CMC regulatory strategy for complex biologics in a fast-growing biotech environment For a fast-growing, internationally active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Regulatory Affairs with a strong CMC focus. Workplace is Region Zug-Zurich in Switzerland, 3d office required. This is a key role within a growing Regulatory Affairs team, contributing to multiple development programs and playing an active part in building high-quality r...
Senior CMC Regulatory Affairs Manager
Alentis Therapeutics, the Claudin-1 Company, is on a mission to treat cancer and reverse fibrosis. To this end, we are rapidly advancing a clinical pipeline of anti-Claudin-1 monoclonal antibodies. Our team is committed to unlocking the broad potential of our therapeutic target Claudin-1 and bringing much-needed medicines to patients suffering from solid tumors as well as kidney, liver, and lung fibrosis. Tasks The Senior CMC Regulatory Affairs Manager is responsible for defining, leading and ex...
Director of CMC Operations
Alentis Therapeutics, the Claudin-1 Company, is on a mission to treat cancer and reverse fibrosis. To this end, we are rapidly advancing a clinical pipeline of anti-Claudin-1 monoclonal antibodies. Our team is committed to unlocking the broad potential of our therapeutic target Claudin-1 and bringing much-needed medicines to patients suffering from solid tumors as well as kidney, liver, and lung fibrosis. Tasks The Director of CMC Operations will oversee and optimize the CMC operations for Alent...
Sachbearbeitung Arzneimittelzulassung (m/w/d)
Wir suchen Dich zum nächstmöglichen Zeitpunkt für die Abteilung Arzneimittelzulassung als Sachbearbeitung Arzneimittelzulassung (m/w/d) Deine Aufgaben: Unterstützung der Regulatory Affairs Manager und CMC Coordinatoren (m/w/d) bei der weltweiten Erstellung, Zusammenführung und Einreichung von Zulassungsdokumenten Korrekte Ablage von Dokumenten im Rahmen unserer Arzneimittelzulassungen Anwendung der hierfür vorgesehenen Software DocuBridge nach intensiver Einarbeitung Weltweite Korrespondenz mit...
Senior CMC Project Manager / Associate Director CMC
Small Molecules | Basel, Switzerland About BioVersys BioVersys is a Swiss clinical-stage biotech company dedicated to the development of innovative antibacterial therapies addressing the global crisis of antimicrobial resistance. With two small molecule assets in clinical development and a strong scientific foundation, BioVersys offers a unique opportunity to contribute to life-saving innovation in infectious diseases within a focused and agile environment. The Role To strengthen our Chemistry, ...
Senior Project Manager CMC & Tech Transfer (gn) (gn)
Dein Aufgabengebiet Leitung von bereichsübergreifenden CMC-Projekten inklusive Verantwortung für sämtliche Themen rund um Herstellung, IMPs und technische Transfers. Führung und Koordination eines interdisziplinären Expertenteams (u. a. QA, QC, Produktion, Regulatory Affairs, Supply Chain, Finanzen) sowie Sicherstellung eines reibungslosen Informationsflusses zwischen allen Beteiligten. Erstellung und Pflege von Projekt-, Budget- und Zeitplänen sowie Überwachung von Fortschritt, Qualität, Termin...