South San Francisco,
Tricida, Inc. is an innovative startup company focused on the discovery and clinical development of novel therapeutics to address renal, metabolic and cardiovascular disease. Tricida is led by a management team with an accomplished and proven track...
DaVinci Biosciences LLC
Who we are
DaVinci Biosciences, LLC is engaged in the discovery and development of cell-based therapeutics and tools that aid in the research for treatment of human degenerative disorders. We have three business units:
• DV Biologics focuses on...
Responsible for managing regulatory activities that support department and company projects and programs. Develops and ensures implementation of strategies and tactics for earliest possible approvals of drug filings and applications. Provides...
NGM Biopharmaceuticals, Inc.
South San Francisco,
NGM Biopharmaceuticals, Inc. is a private, biotech start-up dedicated to discovering the next generation of medicines for the treatment of metabolic and hepatic diseases. Our experienced scientific team has joined forces with an impressive group of...
Responsible for supporting the Regulatory Affairs Department across a number of company-sponsored projects. Under supervision, has primary responsibility for assembling regulatory dossiers for review by senior regulatory affairs...
Halozyme Therapeutics, Inc.
The Regulatory Affairs Specialist 2 (RAS 2) will provide support to the company’s internal and alliance programs for regulatory activities. The RAS 2 will assist with the coordination, planning, creation, review, and approval of...
Facilitate preparation and completion of documentation to support electronic or paper submissions (e.g., IND, CTA, NDA) to FDA and to ex-US regulatory agencies in collaboration with team members from other functional areas and more...
Biotest Pharmaceuticals Corporation
The Director-Regulatory Affairs, supervises departmental operations, developing staff, assigning and reviewing development projects and needs for facilities, to insure attaining corporate goals. Serve as liaison/representative for company's...
NewLink Genetics seeks a full time Director / Associate Director, Clinical Development, in NewLink’s immuno-oncology clinical development program. This individual will be expected to provide medical leadership and content expertise in collaboration...