Associate Director Regulatory Affairs - CMC - (Un-CA-Foster City - 94404)

Minimum Education: Bachelors
Jobcode: 284079
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Reporting to the Head of CMC Regulatory Affairs this person will responsible for leading regulatory activities for assigned projects.They will prepare submissions that are technically complex. This requires extensive interaction with departments outside of Regulatory Affairs. They will be responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned products.This person must hold a scientific degree and have at least 10 years in progressive experience in Regulatory Affairs. An advanced degree is preferred. Director people management and experience as the Regulatory representative on project teams is required. This person needs to fully understand the regulatory process and be able to suggest and support changes to the system.