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
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