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Regulatory Affairs Specialist
Ref No.: 18-03544
Location: San Francisco, California
Under the direction of AD Regulatory Operations, assists in gathering and assembling information necessary for submissions in accordance with regulations and relevant guidelines. Maintains regulatory submissions and correspondence archives for Company sponsored projects, and all company related sections for partner sponsored projects. Provides general administrative support to Regulatory Operations staff including formatting and processing submissions documents, assembling and preparing briefing books for FDA submissions. Follows general instructions to complete projects. Organizes workday to complete mid-term assignments.

Must be able to demonstrate excellent organizational, planning and follow-up skills. Excellent word processing, and graphic documentation skills are required. Must be able to demonstrate a good attention to details and be goal-oriented, and quality conscientious. Strong computer skills in Word, Excel and Adobe Acrobat Pro, with a working knowledge of electronic publishing/file management systems are an asset. Strong oral and written communication skills are required. Must be able to adapt to changing priorities and manage multiple tasks.