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 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

  • 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, 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 16 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...

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    Zug, Schweiz gloor&lang AG Vollzeit

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