The Manager of GCP Compliance leads and directs GCP compliance activities that primarily support the Development Organization. The position helps ensure GCP compliance by assisting with the development and implementation of...
Manage and direct the company’s global regulatory submissions including both US (INDs, NDAs) and ex-US (CTAs,
MAA) filings working with internal functional groups, CROS, and consultants. The incumbent must be well-versed in FDA
and ICH regulations...
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics is a clinical-stage biopharmaceutical company located in Brisbane, California, in the biotechnology hub south of San Francisco. The company is developing desensitization treatments for food...
The Regulatory Affairs Specialist will prepare the regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals with a focus on China and Japan. Assist with ROW submissions as required....