About the RoleThe 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
Key ResponsibilitiesCMC Regulatory Strategy & Leadership - 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.
Regulatory Submissions & Documentation - 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 guidelines in the assessment and management of manufacturing and product changes.
- Critically review CMC documents generated by technical functions, contract manufacturers, testing laboratories, and other external partners for scientific consistency, regulatory adequacy, and alignment with regulatory commitments and approved dossiers.
- Ensure consistency of CMC information across regulatory submissions, source documents, approved applications, and global dossiers.
- Support preparation and maintenance of Module 3 and other CMC components of global regulatory applications throughout the product lifecycle.
- Support responses to health authority CMC questions and information requests and coordinate cross-functional development of technically accurate and regulatorily appropriate responses
Commercial & Post-Approval Lifecycle Management - 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 to determine appropriate regulatory reporting categories and implementation timing.
- Partner with CMC, Quality, Manufacturing, and Supply Chain teams to integrate regulatory requirements into pharmaceutical change-control processes.
- Develop global regulatory implementation strategies that account for differences in approval timelines and reporting requirements across markets.
- Maintain awareness of regulatory commitments, approved conditions, and country-specific requirements to support continued compliance throughout the commercial lifecycle.
- 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 and assess their potential impact on company programs and marketed products.
- Support regulatory assessment of investigations, deviations, out-of-specification trends, manufacturing changes, and other quality or technical matters when regulatory impact assessment is required.
- Provide regulatory input into comparabilitystrategies and supporting data packages for post-approval manufacturing changes.
- Communicate relevant regulatory developments and emerging expectations to CMC and senior leadership
- 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 is 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
Salary DisclosurePay Range: $180,000-195,000 USD (Salary offered will depend on candidate location, market rate adjustments, skills, and relevant experience).
Belite Bio provides a competitive total compensation package that includes base salary, annual incentive bonuses, equity participation, and a full benefit package (health, dental, vision, 401(k), and paid time off).
