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Gilead Sciences Inc
Regulatory Affairs Associate
Seattle, WA 98102 United States
Regulatory Affairs Specialist
The role reports to the Manager in Regulatory Affairs and will provide support for the oncology therapeutic area. With guidance from immediate manager, this position will work to develop and acquire required regulatory skills and knowledge. The ideal candidate will have a BA or BS degree and 2 years of relevant industry experience or a certificate program specific to Regulatory Affairs.
• Provides support in the preparation of regulatory submissions for investigational and commercial products trial applications and supplements to marketing authorizations) in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• May be required to handle routine labeling changes and drug listing.
• With guidance from immediate manager, works to develop and acquire required regulatory skills and knowledge.
• May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
Please submit resume directly to our website at www.gilead.com/careers.
Gilead’s northwest division, in Seattle, WA is an exciting environment and in one of the best locations of the Pacific Northwest. Surrounded by mountains and waterways, our offices are located on the eastside of Lake Union – an urban district situated between the University of Washington and the South Lake Union business and retail corridor.
Education, training, experience:
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