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Regulatory Affairs Assistant - I
Ref No.: 18-14371
Location: Foster City, California
Provides support in the preparation of routine and straight forward regulatory submissions for approved products (e.g. Renewals and supplements to marketing authorizations) in line with regional requirements and scientific and company policies and procedures. May support routine labeling changes and drug listing as required, under 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.Performs filing and data retrieval functions as directed, or in conjunction with departmental SOPs. Performs workflows and procedures regarding document tracking, indexing and retrieving and disseminating information to the Regulatory department.Seeks assistance from appropriate internal and external resources.Strong organization skills and attention to detail, along with the ability to work on a number of projects with tight timelines is required. Strong verbal and written communication skills and interpersonal skills are required.Must be proficient in Microsoft Word and Excel. Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required. Work is performed under the supervision of Regulatory Affairs professionals following detailed instruction with well defined procedures.