Senior Expert Regulatory Affairs - CMC/Biosimilars

Senior Expert Regulatory Affairs - CMC/BiosimilarsShape CMC regulatory strategy for complex biologics in a fast-growing biotech environmentFor 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 regulatory dossiers for biosimilar products.Your ResponsibilitiesAct as a senior regulatory expert with a focus on CMCDefine and support CMC regulatory strategiesLead and review Module 3 documentationContribute to regulatory submissions (EU, US, other markets)Prepare and support Health Authority interactions (EMA / FDA)Author and review briefing books and regulatory documentsCollaborate closely with CMC, Analytical Development, Clinical and external partnersWork in a matrix organization across multiple projectsYour ProfileMSc or PhD in biotechnology, biochemistry, biology or related field7+ years of experience in Regulatory Affairs, focused on biologics / monoclonal antibodies (biosimilars preferred, not mandatory)Strong knowledge of EMA and FDA regulatory proceduresHands-on experience with eCTD publishingExperience with clinical and CMC-related regulatory documentationExcellent communication and organizational skillsCollaborative mindset and ability to thrive in a dynamic, international environmentWhat’s on OfferKey role in a high-growth biotech environmentExposure to complex, high-impact biosimilar programsInternational, collaborative setupCompetitive compensation and attractive benefits jidfffa353pn jit0208pn jiy26pn