Sr Associate Regulatory Affairs

Location: Thousand Oaks, CA
Date Posted: 01-18-2017
Description
Responsible for the development and preparation of CMC components of regulatory filings for one or more products. Responsible for organizing and preparing CMC initial applications for investigational product and marketing authorizations, amendments and post-market supplements, organization and preparation CMC sections of IND annual reports/annual reports of minor changes for specific products. Has experience in pharmaceutical/biotechnology/ or biopharmaceutical manufacturing. Prior regulatory knowledge and experience; CMC experience preferred.

Bachelor’s degree and 1-2 years of directly related
OR
Associate’s degree and 3-5years of directly related experience

Experience:
• Regulatory CMC experience
• Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech regulated industry
or
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