Job Duties: • Support Regulatory CMC Biologics group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications. Qualifications • Must have 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 5 years of Biologic Regulatory CMC experience, including the preparation of Biologic CMC dossiers • At least a Bachelor Degree required. Master's Degree or PhD preferred
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