Career Center
Job Seekers, Welcome to Regulatory Career Connections
Search Filters
Use this area to filter your search results. Each filter option allows for multiple selections.
Fred Hutchinson Cancer Center
Multiple Locations, Washington
University of North Carolina Wilmington
Wilmington, North Carolina
The Henry M. Jackson Foundation for the Advancement of Military Medicine
Bethesda, Maryland
Loading... Please wait.
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.
Loading. Please wait.
Powered By
For assistance please call 888.491.8833 or e-mail candidatesupport@naylor.com