Remote CMC Regulatory Affairs Associate Director

Job Summary

A biotechnology company is seeking a Remote CMC Regulatory Affairs Associate Director.

Core Responsibilities Include:

• Understanding, interpreting and advising on regulations, guidelines, and procedures
• Assessing data with technical functional expertise to solve problems and make good decisions
• Preparing and managing CMC RA content for submissions

Qualifications Include:

• BS degree
• Minimum of 10 years experience in CMC Regulatory Affairs or related experience
• Rare Disease experience
• Successful MAA and NDA submission experience
• Ability to analyze and interpret scientific data and regulations to apply to a rare disease program
• Experienced in Regulatory Agency meetings resulting in successful outcomes