Santa Clarita, California
•
3d ago
Regulatory Affairs Specialist (Small Molecule IND, NDA, Module 3) Job Summary This critical role demands extensive hands-on expertise in modifying regulatory strategies, authoring scientifically robust Chemistry, Manufacturing, and Controls (CMC) documentation within Module 3 of the eCTD, and managing submissions for Investigational New Drug (IND) and New Drug Applications (NDA) specifically for small molecule drugs. Key Responsibilities Submission Authoring & Management: Lead the planning,
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$100