Job Search Results - Biospace
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Your search returned 16 jobs

Sutro Biopharma, Inc.
South San Francisco, CA

The Regulatory Operations Manager will assist with Regulatory submission projects including managing and preparing submissions for Health Authorities in eCTD format and use of required electronic publishing system(s). The Regulatory Operations...

Apex Life Sciences
Redmond, WA

Plan, coordinate and prepare document packages for regulatory submissions, including FDA 510(k), EU Technical Files, Japanese Todokede/Ninsho Documents, Canadian Device License Applications and other license and registration documents Create and...

Alkahest, Inc.
San Carlos, CA

Alkahest is looking for a Director / Sr. Director of Regulatory Affairs who can apply his or her knowledge of global regulations governing pharmaceutical drug development to all aspects of Alkahest’s preclinical and clinical drug development...

Astex Pharmaceuticals, Inc.
Pleasanton, CA

Join a company that’s making a difference in the fight against cancer. Astex Pharmaceuticals,, is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. Astex is a wholly owned...

Technical Resources International Inc.
Bethesda, MD

• Preparing scientific and regulatory documents (e.g. clinical protocols, investigator’s brochures, informed consent forms, annual reports, investigational new drug applications, new drug applications, regulatory correspondence, and clinical summary...

Technical Resources International Inc.
Bethesda, MD

• Overseeing and managing electronic regulatory submissions in support of active and planned investigational applications (INDs, NDAs, BLAs, IDEs, etc.) corporate-wide • Applying knowledge of electronic publishing requirements to ensure compliance...

NGM Biopharmaceuticals, Inc.
South San Francisco, CA

Manager of Regulatory Affairs will be responsible for providing regulatory strategy for therapeutic candidates in the metabolic and oncology space. Responsible for working closely with the Associate Director, Regulatory Affairs to develop regulatory...

City of Hope
Duarte, CA

City of Hope National Medical Center has an immediate need for a Regulatory Affairs Specialist II. The Regulatory Affairs Specialist II is responsible for coordinating and supporting regulatory affairs activities relating to all City of Hope...

Ultragenyx Pharmaceutical Inc.
Novato, CA

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...

MacroGenics, Inc.
Rockville, MD

Summary of Position: This position is for a key team member focused on the development and characterization of high-producing mammalian cell lines for the production of monoclonal antibodies, recombinant proteins and novel molecules. He/she will be...