Senior Regulatory CMC Strategy Leader

Opus Regulatory, Inc.; Northern (KY); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Opus Regulatory seeks a Principal Consultant, Regulatory CMC to provide strategic leadership for CMC development and submissions, guiding cross-functional teams and leading CMC interactions with health authorities.

The role requires extensive experience with US FDA and global health authorities, strong client-facing skills, and the ability to translate complex data into clear regulatory strategies for diverse product modalities.

Qualifications

• Bachelor's degree in a scientific, technical, engineering, or related discipline.
• Minimum of 15 years of progressive pharmaceutical or biotech industry experience, including at least 10 years focused on Regulatory CMC.
• Demonstrated ability to independently develop and lead CMC regulatory strategies for complex drug/biologic programs.

Responsibilities

• Serve as senior Regulatory CMC advisor to client teams, guiding development, manufacturing, analytics, regulatory submissions, and health authority interactions.
• Lead CMC regulatory planning and content strategy for health authority meetings, INDs, NDAs, BLAs, and variations.
• Author/review/oversee Module 3 content and other complex CMC documents; support meetings with FDA/EMA.

Skills

Regulatory leadership

CMC strategy

FDA interactions

Cross-functional leadership

Stakeholder communication

Education

Bachelor's degree in science/engineering

Job description

Opus Regulatory seeks a Principal Consultant, Regulatory CMC to provide strategic leadership for CMC development and submissions, guiding cross-functional teams and leading CMC interactions with health authorities.

The role requires extensive experience with US FDA and global health authorities, strong client-facing skills, and the ability to translate complex data into clear regulatory strategies for diverse product modalities.