Strategic CMC Regulatory Lead - Small Molecules

Belite Bio, Inc.; San Diego (CA); On-site; USD 180,000 - 195,000; Full time

Job summary

Belite Bio is seeking an Associate Director, Regulatory Affairs – CMC to provide strategic and operational regulatory leadership for global CMC activities across development, registration, and post-approval lifecycle management for small-molecule products. You will work with Manufacturing, Quality, and other functions to craft regulatory strategies and submissions.

The role requires deep CMC regulatory expertise, knowledge of post-approval requirements, and a track record supporting marketed

Qualifications

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Pharmacy, Chemical Engineering, Biology, or related field required.
• Advanced scientific degree such as MS, PharmD, or PhD preferred.

Responsibilities

• Lead global CMC regulatory strategies for small-molecule products across development, registration, commercialization, and post-approval.
• Coordinate CMC content for regulatory submissions including NDAs, PAS, and other filings.
• Develop post-approval strategies for global markets (EU, US, other) and manage change controls.
• Review and ensure regulatory adequacy of CMC documentation and technical data packages.
• Advise on regulatory risks, timelines, and regulatory commitments with cross-functional teams.

Skills

Regulatory leadership

CMC expertise

Global regulatory knowledge

Regulatory submissions

Cross-functional collaboration

Regulatory intelligence

Education

Bachelor's degree in Chemistry

Advanced scientific degree (MS/PharmD/PhD)

Job description

Belite Bio is seeking an Associate Director, Regulatory Affairs – CMC to provide strategic and operational regulatory leadership for global CMC activities across development, registration, and post-approval lifecycle management for small-molecule products. You will work with Manufacturing, Quality, and other functions to craft regulatory strategies and submissions.

The role requires deep CMC regulatory expertise, knowledge of post-approval requirements, and a track record supporting marketed