Clinical Operations

Are you interested to join a team that is developing technologies that will shape the future of drug discovery?

Would you like the opportunity to work on a steady stream of high value drug programs in different disease areas?

Location: Fremont, CA

Regulatory Affairs Manager

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.

Qualifications:

  • Bachelor’s degree or higher with 5 years of regulatory affairs experience in the pharmaceutical industry
  • Logical and persuasive communication skills
  • Strong knowledge of GMP, GLP, GCP and FDA and ICH guidelines
  • Experience interacting with CDER
  • Experience managing projects under strict deadlines

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