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...
The Senior Regulatory Affairs Manager serves as the primary regulatory contact for clients with responsibility for managing regulatory timelines and resources to achieve client deliverables on time and within budget. S/he represents the...
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...
Core responsibilities include, but not limited to the following:
• Coordinate regulatory submissions relevant to assigned projects, in accordance with submission and approval requirements, including in functional groups across the organization in...
Ensures compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the reporting of adverse events to regulatory agencies. Develops guidelines and insures the uniform...