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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
Senior Director of Global Regulatory Affairs	California
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Responsible for global regulatory activities through all phases of drug development 2) Develop/implement strategies for earliest possible approvals of phase 1-4 applications 3) Direct and manage the regulatory team 4) Lead cross-functional teams in preparing/reviewing/assembling regulatory submissions 5) Provide expertise in translating regulatory requirements into workable plans 6) Coordinate meetings with regulatory authorities 7) Provide regulatory support to ensure worldwide trial implementation 8) Maintain familiarity with regulations/guidelines governing drug development and approval
Requirements
1) Advanced degree in a scientific discipline 2) 8+ years of experience working in the regulatory affairs department of a drug development company 3) Experience in preparing major regulatory submissions 4) Supervisory experience 5) Excellent communication, collaboration and leadership skills