Senior Director, CMC Regulatory Affairs

New Horizon Medical Solutions LLC.; San Diego (CA); On-site; USD 140,000 - 165,000; Full time

Job summary

Belite Bio seeks an Associate Director of Regulatory Affairs – CMC to provide strategic and operational leadership for global CMC activities across development, registration, commercialization, and post-approval lifecycle management.

Collaborating with Regulatory, Manufacturing, Quality, and Supply Chain, you will guide submissions, assess changes, and ensure regulatory compliance for small-molecule products globally. A strong regulatory mindset and deep CMC expertise are required.

Qualifications

• Bachelor's degree required in chemistry or related field.
• 10+ years of Regulatory Affairs experience in pharma/biopharma.
• Strong knowledge of global post-approval regulatory requirements (FDA, EMA, ICH).
• Experience preparing and reviewing CMC sections of NDAs and variations.

Responsibilities

• Lead global CMC regulatory strategies for small-molecule products across development, registration, and post-approval lifecycle.
• Act as Regulatory CMC partner to cross-functional teams (Manufacturing, Quality, Supply Chain).
• Provide regulatory guidance on drug substance/product manufacturing, formulations, and packaging.
• Review and coordinate CMC content for regulatory submissions (NDAs, PAS, CBE/30).
• Develop strategies for post-approval changes in EU and other markets.
• Support responses to health authority information requests and regulatory questions.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional leadership

Technical writing

Drug development knowledge

Education

Bachelor's degree in Chemistry/Pharmaceutical Sciences/Pharmacy

MS/PhD/PharmD preferred

Job description

Belite Bio seeks an Associate Director of Regulatory Affairs – CMC to provide strategic and operational leadership for global CMC activities across development, registration, commercialization, and post-approval lifecycle management.

Collaborating with Regulatory, Manufacturing, Quality, and Supply Chain, you will guide submissions, assess changes, and ensure regulatory compliance for small-molecule products globally. A strong regulatory mindset and deep CMC expertise are required.