Senior Expert Regulatory Affairs

vor 15 Stunden

Zug, Schweiz gloor&lang AG Vollzeit

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 #J-18808-Ljbffr

  • Senior Expert Regulatory Affairs

    vor 1 Tag

    Zug, Zug, Schweiz gloor&lang AG Vollzeit

    Shape 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...

  • Senior Expert Regulatory Affairs

    vor 1 Tag

    Zug, Zug, Schweiz gloor&lang AG Vollzeit

    Shape 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...

  • Senior Expert Regulatory Affairs

    Vor 2 Tagen

    Zug, Schweiz gloor&lang AG Vollzeit

    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...

  • Senior Expert Regulatory Affairs

    Vor 2 Tagen

    Zug, Schweiz gloor&lang AG Vollzeit

    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...

  • Senior Regulatory Affairs

    vor 15 Stunden

    Zug, Schweiz gloor&lang AG Vollzeit

    A 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...

  • Regulatory Affairs Manager

    Vor 7 Tagen

    Zug, Zug, Schweiz Randstad Switzerland Vollzeit

    For our client, a leading biotechnology company based in canton Zug, we are seeking aRegulatory Affairs Manager.General Information:Start date: ASAPEnd date: 30/06/2026Contract: temporary contract via RandstadWorkplace: Baar, ZugWorkload: 100%Working hours: StandardTask & Responsibilities:Responsible for managing the development and implementation of...

  • Regulatory Affairs Manager

    vor 1 Woche

    Zug, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a Regulatory Affairs Manager (LSW) - RZ for a pharmaceutical establishment. This role is on a contract basis and is located in Zug with hybrid working available. The client is focused on supplying novel solutions for various illnesses. **Responsibilities**: - Accountable for upkeep of product technical files and for current...

  • Sr CMC Regulatory Affairs Project Consultant

    vor 2 Wochen

    Zug, Schweiz Actalent Vollzeit

    Sr CMC Regulatory Affairs Project Consultant On behalf of our client, a biotech company focused on rare diseases, we are looking for a CMC Regulatory Affairs Specialist for a 50% contract position. *Please note that we can only consider EU/Schengen applications, or valid Swiss permit Responsibilities Act as the regulatory referent CMC expert, defining...

  • Intern Regulatory Affairs

    vor 1 Tag

    Zug, Schweiz Viatris Vollzeit

    7087 Mylan Pharma 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 medicines regardless of...

  • Director Regulatory Affairs EU/International

    vor 1 Woche

    Zug, Zug, Schweiz Actalent Vollzeit

    On behalf of our client, a biotech company focused on rare diseases, we are looking for a Director Regulatory Affairs EU/International.This role will work collaboratively with the Regulatory and R&D teams on projects for late-stage development programs. The selected candidate will be tasked with drafting, reviewing and finalizing content and modules for INDs...