Senior Expert Regulatory Affairs
vor 6 Stunden
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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Regulatory Affairs Manager
vor 1 Woche
Zug, Schweiz Johnson & Johnson VollzeitJohnson & Johnson is currently seeking a Regulatory Affairs Manager to join our local Regulatory Affairs team located in Zug, Switzerland. This role will be working in a hybrid working model. We are looking for a highly motivated individual to join our team as a Regulatory Affairs Manager. In this position, you will play a crucial role in ensuring adherence...
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European Regulatory Affairs
vor 2 Wochen
Zug, Schweiz Proclinical VollzeitProclinical are recruiting a European Regulatory Affairs - CTA Liaison for a biotech corporation. This role is on a contract basis and is located in Zug. **Responsibilities**: - Collaborate with regulatory affairs consultants/service suppliers on CTA proposals. - Serve as a representative for EU regulatory affairs at cross-functional study management team...
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Manager/associate Director
vor 2 Wochen
Zug, Schweiz GSK Vollzeit**Site Name**: UK - London - New Oxford Street, Switzerland - Zug, UK - Hertfordshire - Stevenage **Posted Date**: Nov 25 2024 Are you interested in a highly visible regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs CMC role could be an ideal opportunity to...
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Regulatory Affairs Manager
vor 2 Wochen
Zug, Schweiz Proclinical VollzeitProclinical are recruiting a Regulatory Affairs Manager for a biotech corporation. This role is on a contract basis with the ability to work remotely in Europe. **Responsibilities**: - Handle the relationship with the Clinical Research Organisation contracted for some clinical studies. - You will assist with different regulatory proposals to the marketing...
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Global Regulatory Affairs Manager, Vaccines
vor 1 Woche
Zug, Schweiz GSK Vollzeit**Site Name**: Belgium-Wavre, Italy - Siena, Switzerland - Zug, UK - London - New Oxford Street, USA - Maryland - Rockville, Warsaw Rzymowskiego 53 **Posted Date**: Oct 31 2024 **Global Regulatory Affairs Manager, Vaccines Therapeutic Group**: Job purpose: As a **Global Regulatory Affairs (GRA) Manager**, you will join the GRA Vaccines Therapeutic Group in...
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Regulatory Affairs Manager – Permanent Role
vor 1 Woche
Zug, Schweiz AurigaVision AG VollzeitOur client is an established, innovation-focused pharmaceutical company with a strong presence in the Swiss market. The organization operates internationally and is active in several therapeutic areas with a clear commitment to high-quality regulatory standards. For their Swiss affiliate, we are currently seeking aRegulatory Affairs Manager (Ref) –...
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Regulatory Affairs Manager – Permanent Role
vor 1 Woche
Zug, Schweiz AurigaVision AG VollzeitOur client is an established, innovation-focused pharmaceutical company with a strong presence in the Swiss market. The organization operates internationally and is active in several therapeutic areas with a clear commitment to high-quality regulatory standards. For their Swiss affiliate, we are currently seeking aRegulatory Affairs Manager (Ref) –...
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Regulatory Director for Combination Product
vor 1 Woche
Zug, Schweiz SHL Medical AG Vollzeit**Job Overview** The position of the Director Regulatory for Combination Product, Medical Devices and Emerging Technologies is based in the HQ of SHL Medical AG in Zug. It holds overall responsibility for Regulatory matters related to combination products, medical devices and emerging technologies. The holder is responsible for establishing applicable...
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Regulatory Affairs Manager
Vor 4 Tagen
Zug, Schweiz Viatris VollzeitMeda Pharmaceuticals Switzerland GmbH At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted...
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Head of Medical Affairs, International
vor 1 Woche
Zug, Schweiz BridgeBio Vollzeit**About BridgeBio Pharma, Inc.**: BridgeBio is a biopharmaceutical company dedicated to discovering, developing, and delivering transformative medicines for patients living with genetic diseases and genetically defined cancers. Since our founding in 2015, we have built a diverse portfolio of more than 20 drug development programs, ranging from early...
