Beschreibung

Senior Expert Affairs - CMC/BiosimilarsShape CMC biologics in a fast-growing biotech environmentFor a fast-growing, active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Affairs with a strong CMC focus. Workplace is Region Zug-Zurich in Switzerland, 3d office is a key role within a growing Affairs team, multiple development programs an active part in building high-quality dossiers for biosimilarResponsibilities- Act as a senior expert with a focus on CMC- Define and support CMC Module 3 to submissions (EU, US, other markets)- Prepare and support Health Authority interactions (EMA / FDA)- Author and review briefing books and closely with CMC, Analytical Development, Clinical and external partners- Work in a across multiple projectsYour Profile- MSc or PhD in biotechnology, biochemistry, biology or field- 7+ years of experience in Affairs, focused on biologics / monoclonal antibodies (biosimilars preferred, not knowledge of EMA procedures- Hands-on experience with eCTD publishing- Experience with clinical and and mindset and ability to thrive in a dynamic,on Offer- Key role in a high-growth biotech environment- Exposure to complex, high-impact biosimilar setup- Competitive and benefits jid3951655aen jit0417aen jpiy26aen