Massachusetts Institute of Technology (MIT)
The Center for Biomedical Innovation (CBI) at MIT seeks an assistant director to work with the executive director and director of regulatory sciences on a rapidly expanding range of activities associated with the NEWDIGS Adaptive Licensing Program....
Ensure that products manufactured, tested, processed, stored and distributed are compliant with product specification and customer requirements.
Establish quality systems, policies, objectives, initiatives and organizational structure that support...
Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product...
Raptor Pharmaceuticals is seeking an exceptional Regulatory Vice President with the technical expertise, regulatory knowledge, and leadership skills to effectively implement on initiatives and plans. The ideal candidate will be...
HTG Molecular Diagnostics
• Responsible for creating required documents such as SOPs, reagent manufacturing work instructions, incoming material specifications and performance verifications.
• Analyze procedures and production methods to improve quality,...
Shire Pharmaceuticals Group
The Head of Nonclinical Regulatory Submissions is responsible and accountable for the planning, tracking, compilation and delivery of all nonclinical documents for regulatory submissions. The successful group leader is expected to...
Five Prime Therapeutics, Inc.
South San Francisco,
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases. We have leveraged our comprehensive library of human...
Sunesis Pharmaceuticals, Inc.
South San Francisco,
Reporting to the Vice President, Regulatory Affairs, this position will manage the day-to-day regulatory activities of assigned projects for compounds under development. These activities include acting as the regulatory...
Ultragenyx Pharmaceutical Inc.
Why Join Us
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in...
Alexza Pharmaceuticals, located in Mountain View, CA, is focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions, including agitation, acute repetitive...