Associate Director, Regulatory Affairs CMC

Belite Bio is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases with significant unmet medical needs. Built on our proprietary Retinol Binding Protein 4 (RBP4) IP portfolio, our clinical pipeline includes Tinlarebant (LBS-008), an oral therapy currently in late-stage clinical trials (including the Phase 3 DRAGON and PHOENIX studies) for Stargardt disease (STGD1) and Geographic Atrophy (GA) in dry AMD.

At Belite Bio, we are dedicated to developing innovative solutions to treat untreatable conditions and prevent vision loss in patients worldwide. As an early-stage company, we value entrepreneurial thinking, collaboration, accountability and the ability to thrive in fast moving environments.

The Associate Director, Regulatory Affairs – CMC provides strategic and operational regulatory leadership for global CMC activities supporting small-molecule products across development, registration, commercialization, and post-approval lifecycle management. The position partners closely with CMC, Manufacturing, Quality, Supply Chain, and other cross-functional teams to develop regulatory strategies, assess manufacturing and product changes, review CMC documentation, and author and manage CMC-related regulatory submissions.

The successful candidate will bring deep CMC regulatory expertise, strong knowledge of global post-approval requirements and pharmaceutical manufacturing, and demonstrated experience supporting commercially marketed small-molecule products

• Lead the development and implementation of global CMC regulatory strategies for small-molecule products across development, registration, commercialization, and post-approval lifecycle management.
• Serve as the primary Regulatory CMC partner to Pharmaceutical Development, Manufacturing, Quality, Supply Chain, and other cross-functional functions.
• Provide strategic regulatory guidance for drug substance and drug product manufacturing, formulation, manufacturing process, analytical methods, specifications, stability, packaging, container closure systems, and related CMC activities.
• Assess proposed manufacturing and product changes and develop appropriate global regulatory strategies and implementation plans.
• Provide regulatory support for manufacturing scale-up, process optimization, technology transfers, manufacturing site changes, formulation changes, specification changes, analytical method changes, packaging changes, and other product lifecycle activities.
• Advise CMC and Quality teams on the regulatory impact of change controls and ensure regulatory requirements are considered early in technical and operational decision-making.
• Identify CMC regulatory risks and provide practical, risk-based recommendations that support regulatory compliance, product quality, and continuity of commercial supply.

• Review, author (when applicable) and coordinate CMC content for regulatory submissions, including NDAs, amendments, supplements, annual reports, responses to health authority information requests, and other CMC-related submissions.
• Lead preparation and review of post-approval CMC submissions, including Prior Approval Supplements (PAS), Changes Being Effected supplements (CBE/CBE-30), Annual Reportable changes, and other applicable U.S. reporting categories.
• Develop and execute regulatory strategies for global post-approval changes in accordance with applicable regional requirements, including EU Type IA, Type IB, and Type II variations and corresponding requirements in other international markets.
• Apply applicable SUPAC, FDA, EMA, ICH, and other global regulatory…