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About our client
Our client is an emerging biopharmaceutical company that is focused on the development and commercialization of next generation therapeutics for infectious diseases and cancer. The company has an established revenue stream, experienced management staff, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees.
Position	Location
Associate Director of Regulatory Affairs	California
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Coordinate/prepare document packages for regulatory submissions from all areas of the company, internal audits and inspections 2) Compile all materials required in submissions, license renewal and annual registrations 3) Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance 4) Keep abreast of regulatory procedures/changes 5) Recommend strategies for earliest possible approval of trial applications 6) Maintain regulatory filing documents, files to support/ensure GXP compliance, etc.
Requirements
1) Bachelor’s or master’s degree in a scientific discipline 2) 2-5 years of related experience 3) Experience in preparing FDA and/or EU submissions 4) Demonstrated competence in determining appropriate global regulatory requirements for clinical trials