Associate Director, Regulatory Affairs CMC

🕒 Outubro 30

🏄 California – Remoto

🏄 California – Remote

💵 $180.000 - $195.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Belite Bio

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2018

🧬 Biotecnologia

💊 Farmacêutico

🔥 Investimento no último ano

💰 $402.000.000 Post-IPO Equity em 2025-12

Biotechnology • Pharmaceuticals

A Belite Bio é uma empresa biofarmacêutica em estágio clínico que desenvolve terapias inovadoras com base em seu portfólio de propriedade intelectual relacionado à RBP4 (Retinol Binding Protein 4). Seu principal candidato, o tinlarebant (LBS-008), é uma terapia oral desenvolvida para reduzir o acúmulo de substâncias tóxicas nos olhos e está sendo desenvolvido para doenças degenerativas da retina, incluindo a doença de Stargardt autossômica recessiva (STGD1) e a atrofia geográfica (degeneração macular relacionada à idade do tipo seca em estágio avançado). A Belite Bio está conduzindo múltiplos estudos clínicos — incluindo programas de Fase 1b/2, Fase 2/3 e Fase 3, como DRAGON, DRAGON II e PHOENIX — e o tinlarebant recebeu diversas designações regulatórias (Orphan Drug nos EUA, na União Europeia e no Japão; Rare Pediatric Disease; Breakthrough Therapy; Fast Track; e Sakigake). O pipeline da empresa também inclui programas voltados ao tratamento de doenças metabólicas e hepáticas, como a doença hepática gordurosa não alcoólica e o diabetes tipo 2.

Descrição

• 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 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 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 • Identify CMC regulatory risks and provide risk-based recommendations supporting compliance, product quality, and continuity of commercial supply • Review, author when applicable, and coordinate CMC content for NDAs, amendments, supplements, annual reports, health authority responses, and other CMC-related submissions • Lead preparation and review of post-approval CMC submissions, including PAS, CBE/CBE-30, Annual Reportable changes, and other U.S. reporting categories • Develop and execute global post-approval change strategies, including EU Type IA, Type IB, and Type II variations • Apply SUPAC, FDA, EMA, ICH, and other global regulatory guidelines • Review CMC documents from technical functions, contract manufacturers, testing laboratories, and external partners • Ensure consistency of CMC information across submissions, source documents, approved applications, and global dossiers • Support preparation and maintenance of Module 3 and other CMC components of global regulatory applications • Support responses to health authority CMC questions and information requests • Provide regulatory leadership for CMC lifecycle management of commercially marketed products • Evaluate manufacturing, process, site, equipment, formulation, analytical, specification, stability, packaging, and supply-chain changes • Integrate regulatory requirements into pharmaceutical change-control processes • Develop global implementation strategies accounting for differences in approval timelines and reporting requirements • Maintain awareness of regulatory commitments, approved conditions, and country-specific requirements • Lead or support CMC interactions with FDA and other global health authorities • Develop briefing materials, regulatory positions, responses, and supporting documentation for health authority meetings and written communications • Represent Regulatory CMC in discussions regarding manufacturing changes, comparability, specifications, analytical methods, stability, process validation, and other CMC topics • Monitor evolving FDA, EMA, ICH, and other global CMC regulations and guidance • Support regulatory assessment of investigations, deviations, out-of-specification trends, manufacturing changes, and other quality or technical matters • Provide regulatory input into comparability strategies and supporting data packages for post-approval manufacturing changes • Communicate regulatory developments and emerging expectations to CMC and senior leadership

🎯 Requisitos

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Pharmacy, Chemical Engineering, Biology, or a related scientific discipline required • Advanced scientific degree such as MS, PharmD, or PhD preferred • 10+ years of Regulatory Affairs experience in the pharmaceutical or biopharmaceutical industry, with substantial experience focused on CMC regulatory affairs • Demonstrated Regulatory CMC experience with small-molecule drug products required • Prior experience supporting commercially marketed products and post-approval CMC lifecycle management required • Demonstrated experience with U.S. post-approval change requirements, including SUPAC, PAS, CBE/CBE-30, and Annual Reportable changes • Strong knowledge of global post-approval regulatory requirements, including EU variation classifications and procedures (Type IA, IB, and II) • Demonstrated experience preparing, reviewing, and managing CMC sections of NDAs and other marketing applications, supplements, variations, amendments, and responses to health authority information requests • Strong understanding of small-molecule pharmaceutical development and manufacturing, including drug substance and drug product manufacturing, process validation, scale-up, technology transfer, analytical methods, specifications, stability, and packaging • Experience assessing regulatory impact and reporting requirements for manufacturing site transfers, process changes, formulation changes, analytical method changes, specification changes, scale changes, and other commercial manufacturing changes • Working knowledge of FDA, EMA, ICH, and other major global CMC regulatory requirements and guidelines • Experience working with internal manufacturing organizations, Quality functions, CMOs/CDMOs, testing laboratories, and other external technical partners • Experience interacting directly with FDA and/or other global health authorities on CMC matters preferred • Experience supporting solid oral dosage forms preferred • Strong scientific and regulatory judgment with the ability to independently assess complex CMC changes and translate technical information into clear regulatory strategies • Excellent technical writing and regulatory submission writing skills • Strong critical-review skills and demonstrated ability to identify gaps, inconsistencies, and regulatory risks within CMC documentation • Ability to provide clear, practical regulatory recommendations to CMC, Quality, Manufacturing, Supply Chain, and senior leadership • Strong written and verbal communication skills with the ability to influence cross-functional teams • Detail-oriented, proactive, and able to manage multiple priorities in a fast-paced, matrixed environment • Strong organizational and project-management capabilities with demonstrated ability to manage multiple submissions and global implementation timelines • Experience working effectively across global teams and time zones

🏖️ Benefícios

• Annual incentive bonuses • Equity participation • Health insurance • Dental insurance • Vision insurance • 401(k) • Paid time off • Reasonable accommodations for individuals with disabilities

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