Ardea Biosciences, Inc. a wholly owned subsidiary of Astra Zeneca based in San Diego is a Biotechnology Company focused on the development of small molecule therapeutics for the treatment of serious diseases.
Ardea Biosciences Regulatory Affairs team has a need for a temporary Regulatory Affairs Coordinator to join the team. The successful candidate will be responsible for providing support to Regulatory Affairs. In the process the candidate will gain knowledge of drug development in the Pharmaceutical Industry.
Primary Duties and Responsibilities
Organizes and maintains confidential files and records.
Assists regulatory operations with regulatory submissions, compiling both electronic and hard-copy documentation, preparing shipments and tracking shipments.
Assists regulatory operations with tracking, logging, and maintenance of correspondence files.
Review regulatory documentation packages prior to drug release to clinical sites
Assists in the document upload and maintenance of the company-wide electronic document management system.
Performs detailed quality control of data tables.
Assist with formatting documents utilizing templates to assure consistency and adherence to style guide standards are met.
Assist with publishing and document formatting QC to ensure compliance with industry and Company-defined standards.
Assists with special projects as needed.
Carries out job responsibilities and assignments safely and maintains a clean and safe work area.
Other duties as necessary.