Senior Expert Regulatory Affairs

vor 1 Tag

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 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 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 Profile MSc 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 Offer Key role in a high-growth biotech environmentExposure to complex, high-impact biosimilar programsInternational, collaborative setupCompetitive compensation and attractive benefits

  • Senior Expert Regulatory Affairs

    vor 1 Tag

    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 4 Tagen

    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 4 Tagen

    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 5 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 4 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 5 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 4 Tagen

    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...

  • Principle, Commercial Regulatory Affairs

    vor 1 Tag

    Zug, Schweiz Novocure Vollzeit

    JOB SUMMARY:The Principal Regulatory Affairs Specialist is part of the Novocure Global Regulatory Affairs (RA) team. In this role, you will be a critical interface between regulatory strategy and commercial execution, ensuring that launch readiness, indication expansion initiatives, promotional and advertising materials for our medical device products comply...

  • Regulatory Affairs Manager

    vor 1 Woche

    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 2 Wochen

    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...