Senior Expert Regulatory Affairs
Vor 3 Tagen
Senior 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, 3‑day 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 Responsibilities Act as a senior regulatory expert with a focus on CMC Define and support CMC regulatory strategies Lead and review Module 3 documentation Contribute to regulatory submissions (EU, US, other markets) Prepare and support Health Authority interactions (EMA / FDA) Author and review briefing books and regulatory documents Collaborate closely with CMC, Analytical Development, Clinical and external partners Work in a matrix organization across multiple projects Your Profile MSc or PhD in biotechnology, biochemistry, biology or related field 7+ years of experience in Regulatory Affairs, focused on biologics / monoclonal antibodies (biosimilars preferred, not mandatory) Strong knowledge of EMA and FDA regulatory procedures Hands‑on experience with eCTD publishing Experience with clinical and CMC‑related regulatory documentation Excellent communication and organizational skills Collaborative mindset and ability to thrive in a dynamic, international environment What’s on Offer Key role in a high‑growth biotech environment Exposure to complex, high‑impact biosimilar programs International, collaborative setup Competitive compensation and attractive benefits Interested? We are looking forward to get in touch with you. Online application #J-18808-Ljbffr
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Senior Regulatory Affairs: CMC
Vor 3 Tagen
Zürich, Schweiz gloor & lang consultants VollzeitA leading biotech firm in Zurich is seeking a Senior Expert in Regulatory Affairs to shape CMC regulatory strategies for complex biologics. This crucial role requires 7+ years of experience in Regulatory Affairs, knowledge of EMA and FDA procedures, and a background in biotechnology. The position offers competitive compensation and the opportunity to work on...
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Regulatory Affairs Professional
vor 2 Wochen
Zürich, Schweiz nemensis ag VollzeitOverviewNavigate Complex Regulatory Landscapes – Join Our Expert NetworkTalent Pool Registration: Building our Regulatory Affairs networkOpportunities: Permanent and temporary positions availableBuilding Our Regulatory Affairs Talent NetworkWe are actively building a comprehensive talent pool of Regulatory Affairs professionals for our diverse client...
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Regulatory Affairs Manager
vor 1 Woche
Zürich, Schweiz Proclinical VollzeitShape the future of vaccines-drive regulatory excellence across Europe. Proclinical is seeking a Regulatory Affairs Manager for a contract role based in Switzerland. This position focuses on supporting regulatory activities related to the development, registration, and lifecycle management of vaccine candidates in Europe. The role offers flexibility with...
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Leiter:in Quality Management
vor 1 Woche
Zürich, Schweiz CISTEC AG VollzeitLeiter:in Quality Management & Regulatory Affairs (80 – 100%) Die CISTEC AG ist ein erfolgreiches KMU und sucht laufend qualifizierte und motivierte Mitarbeiter: innen. Wenn du Interesse hast, bei einem innovativen Software- und Dienstleistungsunternehmen im Gesundheitswesen tätig zu sein, melde dich bei uns. Aufgrund unseres Wachstums suchen wir für...
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Regulatory Affairs Manager
vor 2 Stunden
Zürich, Schweiz RM IT Professional Resources AG Vollzeit**Regulatory Affairs Manager - Marketed Products Development, GEM** vacancy (requiring profound Pharma knowledge) for our Glattpark (Opfikon) based client in the Pharma sector**.** **Your tasks**: - Collaborates to define, develop and lead Marketed Products GEM strategies to maximize regulatory success towards achievement of program objectives -...
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Leiter:in Quality Management
vor 15 Stunden
Zürich, Schweiz CISTEC AG VollzeitDie CISTEC AG ist ein erfolgreiches KMU und sucht laufend qualifizierte und motivierte Mitarbeiter: innen. Wenn du Interesse hast, bei einem innovativen Software- und Dienstleistungsunternehmen im Gesundheitswesen tätig zu sein, melde dich bei uns. Aufgrund unseres Wachstums suchen wir für unser Team eine:n Leiter:in Quality Management & Regulatory...
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Regulatory Affairs Manager
Vor 5 Tagen
Zürich, Schweiz Takeda Pharmaceutical Vollzeit**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.** Our team is growing and for this we need bright minds with creativity and flexibility - what talent do...
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Leiter:in Quality Management
vor 1 Woche
Zürich, Zürich, Schweiz CISTEC AG VollzeitDie CISTEC AG ist ein erfolgreiches KMU und sucht laufend qualifizierte und motivierte Mitarbeiter: innen. Wenn du Interesse hast, bei einem innovativen Software- und Dienstleistungsunternehmen im Gesundheitswesen tätig zu sein, melde dich bei uns. Aufgrund unseres Wachstums suchen wir für unser Team eine:n Leiter:in Quality Management & Regulatory...
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Regulatory Expert Gmp
vor 2 Wochen
Zürich, Schweiz Universität Zürich Vollzeit**Zürich Hub für Wirkstoff - und Medizinproduktentwicklung (ZH3D)** **Regulatory Expert GMP 80 - 100 %**: Stellenantritt 01.10.2025 Die Universität Zürich (UZH) ist eine führende Institution, die für ihre Exzellenz in Forschung und Lehre bekannt ist. Mit einer lebendigen wissenschaftlichen Gemeinschaft und einem Schwerpunkt auf interdisziplinärer...
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Zürich, Schweiz Eidgenössische Technische Hochschule Zürich VollzeitQuality & Regulatory Affairs Specialist (QARA) – Class III Medical Device At Veltist – a Wyss Zurich project – we are reshaping post-operative care through our platform technology AnastoSeal, enabling the next generation of implantable biomaterials for sealing, healing, and integration with human tissue. Veltist is a pioneering MedTech spin-off from...
