Amicus Therapeutics, Inc.
Amicus Therapeutics (NASDAQ:FOLD) is a biopharmaceutical company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of novel, first-in-class treatments in development for a broad range of...
Portola Pharmaceuticals, Inc.
South San Francisco,
Portola Pharmaceuticals, Inc. was founded in 2003 and is headquartered in South San Francisco, Calif. We completed an initial public offering in May 2013 and are traded on the Nasdaq Stock Market under the symbol PTLA. We have approximately 80...
This position is responsible for supporting the activities of Regulatory Affairs with an emphasis on global regulatory issues and the preparation, review, and evaluation of documents for Versartis’ product submissions and regulatory communications. ...
Document Security Administrator
Location: Cambridge MA
We are currently looking for an individual who can play a key role in the configuration, implementation, and ongoing oversight and management of an electronic document management system. This...
Ultragenyx Pharmaceutical Inc.
Why Join Us
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rate and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. We are...
The Regulatory Affairs Specialist will maintain Cepheid change control process to provide input and supply documentation on whether changes require new regulatory submissions with the United States FDA and International Regulatory Agencies.
Ardea Biosciences, Inc.
Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases.
We are searching for a...
Technical Resources International Inc.
Founded in 1979, Technical Resources International, Inc. (TRI) is a Contract Research Organization that provides a unique range of support services in the areas of Health, Communications, and Information Technology to both private industry and...
Dart NeuroScience LLC
Working in a team environment, the Regulatory Affairs Senior Manager will be responsible for executing regulatory strategy as well as hands-on management of all technical and operational aspects related to the regulatory lifecycle (e.g., from...
South San Francisco,
The Regulatory Submissions Editor is responsible for the preparation of high-quality submission-ready documents through effective implementation of writing and review processes. This position interfaces with multiple functional groups (e.g.,...