Archiviertes Projekt - Regulatory Affairs Manager -CMC
The position is permanent and based in Geneva.
review and writing CMC documentation (CTD sections, IMPD or briefing books etc.) for Health Authority submissions for small molecules and biological products.
Manage global and regional submissions such as clinical trial applications, new marketing authorization applications, lifecycle management activities and responses to Health Authority questions.
Provide leadership on regulatory interactions on CMC related topics, lead preparation of meetings with regulatory agencies and ensure CMC regulatory issues impacting global regulatory strategy for proposed CMC filings are considered.
Proactively participate in design of global regulatory strategies for the development of therapeutic and diagnostic products in adherence to regulatory guidelines,
Represent Global Regulatory CMC on interdisciplinary project teams; partner with Regulatory, Quality, Research, Manufacturing, Nonclinical and Clinical teams - Assist during regulatory agency inspections.
Participate in regulatory intelligence activities; monitor regulatory guidelines and trends
Life science degree.
several years of experience in regulatory affairs role in the pharmaceutical/biotechnology/life science industry including both development and commercial pharmaceutical products
writing experience of CMC regulatory documents, proven participation to EMA CP application or FDA BLA.
Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities.
Demonstrated verbal and written communication skills.
Ability to multi-task, pay close attention to detail, and follow projects through to completion.
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