We are seeking a regulatory affairs manager who is ready to help develop and implement our regulatory plans for clinical trials. This is an opportunity to shape our regulatory compliance efforts and be part of building a world-class clinical operation from the ground up that sets the standard for efficiency and quality.
In this role, you will be managing all regulatory activities. Your range of duties will include supporting the generation and implementation of SOPs, supporting document management efforts, preparing document packages for regulatory submissions in electronic formats, and supporting the quality system in compliance with FDA and ICH requirements.
Location: Fremont, CA