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Regulatory Affairs Associate
Ref No.: 18-01490
Location: San Francisco, California
Responsible for supporting the Regulatory Affairs Department across a number of company-sponsored projects. Primarily responsible for ancillary dossier preparation activities. Under the direction of senior regulatory affairs staff, assists in the processing, assembly and archiving of regulatory submissions for Company and partner sponsored global regulatory submissions. Locates and obtains supportive information necessary for submissions in accordance with regulations and relevant guidelines. Through formal and one-one training, becomes familiar with the laws, regulations and guidelines governing drug development and approval. Under the direction of senior regulatory affairs staff, maintains regulatory submissions and correspondence for Company sponsored projects, and all Company related sections for partner sponsored projects, including Letters of Authorization and product label reviews . Under the direction of senior regulatory affairs staff, provides input on timelines for submissions. Follows general instructions to complete projects. Organizes workday to complete mid-term assignments. Supports other projects as needed, which will include but not be limited to performing research and compiling materials to develop regulatory strategies.

Organizational, planning and follow-up skills, as well as word processing 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, with a working knowledge of electronic publishing/file management systems and document management systems are an asset. Ability to use the Internet for research applications is required. Expected to gain understanding of current US regulatory requirements, guidelines and regulations. Strong oral and written communication skills are required. Must be able to adapt to changing priorities and manage multiple tasks.