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...
Summary of Position:
Reporting to the CEO, the Vice President of Regulatory Affairs will be responsible for developing the global regulatory strategy for development-stage programs including CMC, regulatory submissions, regulatory compliance,...
Balboa Nephrology Medical Group
California Institute for Renal Research is searching for a new team member. The position is for a full time Regulatory Coordinator Assistant with 3+ years of experience assisting the Clinical Research Operations Manager and Clinical Research...
Revance Therapeutics, Inc.
The Regulatory Affairs Associate provides support for the preparation, submission and archival of accurate information to Health Authorities ensuring compliance with regional registration requirements, company policies and procedures under the...
Ajinomoto Althea, Inc.
Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.
Now is an exciting time to...
Orexigen Therapeutics Inc.
The Senior Manager, Regulatory Operations is responsible for the oversight and management of day-to-day Regulatory submission processing to Global Health Authorities (i.e., FDA, EMA, etc.). This position is also responsible for the development and...
South San Francisco or Sunnyvale,
Pharmacyclics, an AbbVie Company, based in Sunnyvale, CA represents the single largest acquisition AbbVie has ever made, and is key to AbbVie’s corporate strategy to add another very significant growth platform and diversification. Pharmacyclics...
Responsible for ensuring clinical processes are conducted in accordance with guidelines and regulations. Develops, performs, and manages quality assurance activities. Manages audits and chairs review committees.
• Coordinate and prepare product submissions (pre and post market) for FDA and other major market regulatory agencies
• Create and maintain Technical Files, Design History Files, and Device Master Records
• Provide post market support for all...
Five Prime Therapeutics, Inc.
South San Francisco,
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a clinical-stage biotechnology company focused on discovering and developing transformative protein-based medicines for patients with serious unmet medical needs. The company has an emerging portfolio...