Senior Manager Regulatory Affairs CMC

A company is looking for a Senior Manager/Associate Director in Regulatory Affairs CMC. Key Responsibilities Contribute regulatory CMC expertise to product development and registration for small molecule investigational products Oversee the preparation and review of CMC documents for regulatory submissions, ensuring compliance and timely delivery Collaborate with cross-functional teams and external vendors to support regulatory milestones and strategies Required Qualifications, Training, and Education BS/BA degree in a scientific or health sciences discipline 5+ years of experience in CMC Regulatory Affairs Experience in rare disease is a plus Familiarity with Veeva RIM or similar document management systems Proven ability to manage timelines and processes for CMC submissions

Feb 20, 2025 - 13:27

A company is looking for a Senior Manager/Associate Director in Regulatory Affairs CMC. Key Responsibilities Contribute regulatory CMC expertise to product development and registration for small molecule investigational products Oversee the preparation and review of CMC documents for regulatory submissions, ensuring compliance and timely delivery Collaborate with cross-functional teams and external vendors to support regulatory milestones and strategies Required Qualifications, Training, and Education BS/BA degree in a scientific or health sciences discipline 5+ years of experience in CMC Regulatory Affairs Experience in rare disease is a plus Familiarity with Veeva RIM or similar document management systems Proven ability to manage timelines and processes for CMC submissions