Senior Expert Regulatory Affairs
vor 4 Wochen
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 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
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Senior Expert Regulatory Affairs
Vor 3 Tagen
Zug, Zug, Schweiz gloor&lang AG VollzeitShape 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...
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Senior Expert Regulatory Affairs
Vor 3 Tagen
Zug, Zug, Schweiz gloor&lang AG VollzeitShape 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...
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Senior Expert Regulatory Affairs
vor 3 Wochen
Zug, Schweiz gloor&lang AG VollzeitShape 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...
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Senior Expert Regulatory Affairs
Vor 4 Tagen
Zug, Schweiz gloor&lang AG VollzeitShape 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...
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Executive Director, Regulatory Affairs
Vor 3 Tagen
Zug, Schweiz Mirati Therapeutics Inc Vollzeit**Job Description Summary** Reporting to the SVP and Head of International, based in Zug, and the VP Regulatory Affairs & Quality, based in San Diego, this professional will be part of both the International Leadership and the Global Regulatory Affairs Teams with responsibility for oversight of EU and International Regulatory activities to support corporate...
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Senior Regulatory Affairs
vor 3 Wochen
Zug, Schweiz gloor&lang AG VollzeitA leading biotech company located in Zug is seeking a Senior Expert in Regulatory Affairs with a strong CMC focus. The candidate will play a key role in defining regulatory strategies, authoring essential documents, and supporting health authority interactions. With at least 7 years of experience and a related MSc or PhD, the candidate will thrive in a...
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Drug Regulatory Affairs Manager
vor 2 Wochen
Zug, Schweiz nemensis ag VollzeitAt nemensis ag, we have connected thousands of applicants with their dream job and given them the opportunity to develop or re-enter the job market. For our client, an international pharmaceutical company in Rotkreuz, we are looking for a Drug Regulatory Affairs Manager. **Job Purpose**: Takes care of all drug regulatory affairs matters regarding the...
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Executive Director, Regulatory Affairs
vor 1 Tag
Zug, Zug, Schweiz Vaxcyte VollzeitJoin our Mission to Protect Humankind Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group...
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Zug, Schweiz BioTalent Vollzeit**Snr Director Regulatory - Contract**: In collaboration with a well funded fast paced BioTech, BioTalent are looking to connect a seasoned Regulatory Industry professional to fulfil EU and UK requirements in alignment with the Global Team. This role will offer you - 3-6 month rolling contract - Ability to work part time - Hourly pay rate - Remote...
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Regulatory Affairs Manager
vor 1 Tag
Zug, Schweiz Merck Group VollzeitWork Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...
