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Senior Director, CMC
Hurley Consulting Associates, Ltd. is seeking a CMC Regulatory Affairs professional to join our Regulatory Affairs group. M.S. or advanced degree preferred with at least 15+ experience in areas such as R&D, CMC and Quality Assurance in the pharmaceutical industry. The responsibility will include: Prepare or review CMC technical documents, CTD Module 2, 3 and Module 3 for submissions. Review of CTD Module 2.3 and Module 3 for technical content and compliance with regulatory requirements. Participate in the development of global CMC regulatory strategies. Manage novel compound contract manufacturing for drug substances and drug products Knowledge of CMC, FDA, EMA and ICH guidelines. Experience with IND preparation and IND amendments, NDA s
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