Senior Manager, CMC Regulatory Affairs

Job Summary

A company is looking for a Senior Manager, CMC Global Regulatory Affairs.

Key Responsibilities

• Develop and implement global CMC regulatory strategies for late-stage development and marketing applications
• Plan, prepare, and review CMC sections of regulatory submissions and lead responses to Health Authority inquiries
• Represent CMC RA in project team meetings and provide regulatory guidance to cross-functional teams

Required Qualifications

• BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline
• 7+ years in Regulatory Affairs CMC with experience in small molecules
• Proven track record in late-stage development and marketing applications as the CMC Regulatory lead
• Experience with biologic, peptide, or oligonucleotide products is preferred
• RAC certification is a plus