Associate Director, CMC Regulatory Affairs (Small Molecules) (Remote

Senior Manager, CMC Regulatory Affairs (Small Molecules) Position Summary

The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs. This role leads the development and execution of global CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management activities for small molecule drug products, with primary emphasis on oral solid dosage forms including tablets and capsules.

The Senior Manager serves as the primary CMC Regulatory Affairs representative on cross-functional teams and partners closely with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management to ensure alignment of CMC development plans with global regulatory requirements and business objectives. This position requires extensive experience supporting small molecule drug product development from IND through commercialization, with significant expertise in oral solid dosage forms, drug product manufacturing, formulation development, analytical methods, process validation, and lifecycle management.

Experience supporting biologics or biotechnology products is considered a plus but is not required. The individual will be responsible for driving global CMC regulatory submissions, leading Health Authority interactions related to CMC topics, assessing regulatory risks, and supporting successful product approvals and post-approval activities across major global markets, including the United States (FDA), Europe (EMA), Gulf Cooperation Council (GCC) countries, and Japan (PMDA).

• Develop and implement global CMC regulatory strategies to support clinical development, registration, commercialization, and lifecycle management of small molecule pharmaceutical products.
• Serve as the CMC Regulatory lead on cross-functional program teams, providing strategic regulatory guidance throughout product development and commercialization.
• Partner with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, and Regulatory Operations to ensure CMC activities support regulatory objectives and submission timelines.
• Assess regulatory risks, develop mitigation strategies, and provide strategic regulatory recommendations to support program goals and business priorities.
• Provide regulatory support for products from IND through NDA approval and post-approval lifecycle management, including expedited development pathways where applicable.
• Lead preparation, review, and submission of CMC documentation for global regulatory filings, including INDs, CTAs, IMPDs, NDAs, MAAs, amendments, supplements, variations, annual reports, and responses to Health Authority questions.
• Author and review Module 2 and Module 3 CMC documentation, ensuring technical accuracy, consistency, and compliance with global regulatory requirements.
• Coordinate cross-functional contributions to global CMC regulatory submissions and ensure compliance with regional regulatory expectations.
• Lead CMC regulatory activities supporting initial marketing applications and global registration strategies.
• Serve as the primary CMC representative for Health Authority meetings and responses to regulatory questions.
• Support inspection readiness and regulatory assessments related to manufacturing, quality systems, and product quality.
• Develop global filing strategies for post-approval CMC changes, including manufacturing process improvements, formulation changes, specification updates, analytical method changes, manufacturing site transfers, technology transfers, process validation, stability updates, and supplier changes.

• Provide strategic regulatory guidance for development and commercialization of small molecule pharmaceutical products, with primary emphasis on oral solid dosage forms including tablets, capsules, and related modified-release formulations.
• Collaborate with Pharmaceutical Development and Manufacturing teams to support formulation development, process development, scale-up, technology transfer, process validation, and commercial manufacturing.
• Evaluate regulatory impact of manufacturing changes involving active pharmaceutical ingredients (APIs), excipients, formulation development, manufacturing processes, packaging systems, and commercial manufacturing sites.
• Support regulatory strategies for technology transfers, manufacturing site changes, alternate suppliers, and lifecycle management activities.
• Provide regulatory oversight and strategic guidance for analytical method development, validation, specifications, and stability programs supporting product quality and regulatory compliance.
• Contribute to regulatory assessments of critical…