Associate Director, Regulatory Affairs CMC

Belite Bio, LLC•San Diego, CA

8d•$140,000 - $165,000

About The Position

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.

Requirements

Bachelor's degree in Chemistry, Pharmaceutical Sciences, Pharmacy, Chemical Engineering, Biology, or a related scientific discipline required
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.
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

Nice To Haves

Advanced scientific degree such as MS, PharmD, or PhD preferred
Experience interacting directly with FDA and/or other global health authorities on CMC matters preferred.
Experience supporting solid oral dosage forms is preferred

Responsibilities

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 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.
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 comparability strategies and supporting data packages for post-approval manufacturing changes.
Communicate relevant regulatory developments and emerging expectations to CMC and senior leadership.