Regulatory Affairs jobs in San Ramon, CA

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SR MANAGER/AD REGULATORY AFFAIRS CMC (SMALL MOLECULES)

Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictions. Oversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulato...

CompanyBiospace
AddressSan Francisco, CA
CategoryInformation Technology
Job typeFull time
Date Posted 2 days ago See detail

Sr Manager/AD Regulatory Affairs CMC (small molecules)

Biospace

San Francisco, CA

Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictions. Oversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulato...

Head/ Sr Director of Global Regulatory Affairs

Predicine, Inc

Hayward, CA

Responsible for setting strategy and leading the Predicine Global Regulatory Affairs organization. Organize and oversee the preparation, review, and submission of regulatory documents to regulatory authorities for In vitro diagnos...

Director, Clinical Regulatory Affairs

Cymabay Therapeutics

Newark, CA

Work with Vice President to devise regulatory strategies to ensure rapid and timely approval of products. Develop global regulatory plans to facilitate the progress of programs in all phases of development. Identify risk mitigatio...

Regulatory Affairs Senior Program Manager

Biospace

San Francisco, CA

6+ years of Regulatory Affairs experience in the biopharmaceutical industry or equivalent Pref Knowledge of regulatory requirements and early to mid-clinical stage experience with US regulatory submissions for therapeutic products...