Experience preparing CMC regulatory documents and/or manuscripts is desired. developing assignments and jobs for you who are a specialist in life science.
Minimum of 2-5 years in a Regulatory Affairs CMC role. Experience in plasma-derived therapies or biologics preferred. Global regulatory CMC experience preferable. Advanced degree preferred, such as PhD, MD or JD. Other Job Requirements ~15-20% national and international travel anticipated. WHAT TAKEDA CAN OFFER YOU:
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Experienced CMC professional serving as project leader responsible for the development of CMC regulatory strategies, submissions and compliance activities for pharmatherapeutic development programs and commercial products supporting the Pfizer Biopharmaceuticals Group Hospital Category Business Unit, specifically Anti-Infectives, independently or with minimal supervision.
Provide regulatory support and advice for internal and external customers in line with defined regulatory plans and in response to ad-hoc questions. Search Regulatory affairs cmc manager jobs.
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Senior Manager, Regulatory Affairs, CMC. San Rafael, California Senior Associate/Manager Regulatory Affairs (TEMPORARY).
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Aktuell 6 CMC Regulatory Jobs ☆ Freie Stellen wie zB: ☛ Regulatory Affairs CMC Senior Manager (m/f/x) Biologics bei Novartis Jetzt schnell und unkompliziert bewerben! Maintain CMC related submission information in the relevant systems, track regulatory com-mitments and timelines for specific projects/products/markets. With minimal supervision, plan, author and manage the assembly and timely submission of CMC related sections of IMPDs, INDs, NDAs, MAAs, post approval, renewal, line extensions and other dossiers to meet filing requirements. 2021-03-10 · Job Title: Associate/ Senior Associate CMC Regulatory.
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Operations Regulatory CMC - Manager - Poolia Life Science & Engineering AstraZeneca is a global, innovation-driven biopharmaceutical
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