This individual will be the representative for assigned project(s) (i.e., INDs, IND amendments, annual reports, FDA meeting packages, NDAs, NDA amendments, etc.) He/she will functions as a Project Manager, working with other departmental and...

Lead and direct the activities of Analytical Development department in the Nektar Pharmaceutical Development and Manufacturing organization. Responsible for product characterization, analytical method development, process development support and...

The Senior Associate / Manager, Regulatory Affairs is responsible for supporting regulatory activities; will coordinate and prepare documents for submissions; contribute to the completion of projects and ensure compliance with required regulations. ...

The Senior Director, Regulatory Affairs is responsible for pre- and post-approval regulatory compliance for advertising, labeling, and promotional information, along with strategy, leadership, planning and execution for Raptor Pharmaceuticals. The...

Vertex Pharmaceuticals seeks an experienced and innovative physician-scientist to lead our global Clinical Biomarkers function from our corporate headquarters in Cambridge, MA. Reporting to the Vice President of Translational Medical Sciences, the...

Together, We Can Solve the World’s Greatest Challenges The solution to many of the most fundamental challenges facing the world today can be found in science. But providing for the food, energy and safety needs of a growing population will require...

This position will be responsible for conducting reviews of domestic and international sample and site-specific informed consent documents for compliance with applicable federal regulations and policies; providing expertise on the implementation of...

• Prepare and maintain Informed Consent Templates used to prepare Sample Informed Consents • Perform regulatory review of the protocol sample informed consent and the informed consent submitted by clinical sites • Prepare, update, and maintain lists...

Founded in 1979, Technical Resources International, Inc. (TRI) provides a unique range of support services in the areas of Communications, Health and Information Technology to both private industry and government agency clients. TRI is currently...

Perseid Therapeutics LLC's mission is to develop protein drugs to improve human health with an initial focus on patients suffering from disorders treatable by immune suppressive therapy. We use our proprietary technologies to discover, research and...