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Regulatory Affairs Manager (Fluent in English and Mandarin (Nantong Dialect)
SUMMARY:  Responsible for managing Regulatory Affairs for the US facility and fulfill US Agent responsibilities for all foreign Siegfried sites.  Responsible for managing/supporting US and China drug master files for the US and Global Siegfried API facilities. Support registration activities for Siegfried in China, through our Chinese affiliate or local agents. Support maintenance of FDA Drug Registrations, FDA Substance Listings, and State Licenses. ESSENTIAL DUTIES AND RESPONSIBILITIES: Prepare regulatory documentation for assigned products for submission to the regulatory agencies or customers: Submit CMC Drug Substance Submissions. Prepare eCTD files and transmit through regulatory on-line portals.


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