Senior Manager Regulatory Affairs

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). Essential Functions CMC Regulatory Strategy, Submissions & Dossier Development 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. Technical Leadership for Small Molecule Drug Products 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 material attributes (CMAs), critical process parameters (CPPs), critical quality attributes (CQAs), control strategies, and pharmaceutical development throughout product development and commercialization. Provide CMC regulatory support for combination products or biologic products when applicable; prior biologics experience is considered advantageous but is not a primary requirement. Requirements Education Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry, or a related scientific discipline required. Advanced degree (MS, PharmD, PhD, or equivalent) preferred. Experience Typically 8-12+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry, including significant CMC Regulatory Affairs experience. Demonstrated experience supporting small molecule pharmaceutical products from IND through commercialization and post-approval lifecycle management. Extensive experience supporting oral solid dosage forms, including tablets, capsules, and related drug product manufacturing. Experience supporting both early-stage development (IND/Phase 1) and commercial products, including post-approval regulatory activities. Demonstrated experience preparing and managing global CMC regulatory submissions, including INDs, CTAs, IMPDs, NDAs, MAAs, amendments, supplements, annual reports, and variations. Experience supporting global regulatory activities with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Gulf Cooperation Council (GCC) regulatory authorities, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Experience supporting manufacturing process development, formulation development, process validation, technology transfer, and commercialization of small molecule drug products. Experience leading or supporting Health Authority interactions related to CMC topics. Demonstrated experience managing post-approval CMC changes, including manufacturing changes, site transfers, specification updates, analytical method changes, supplier changes, and lifecycle management activities. Experience supporting biologics or biotechnology products is desirable but not required. Experience supporting rare disease products or orphan drug development is preferred. Knowledge, Skills & Abilities Regulatory & Strategic Expertise Comprehensive understanding of CMC regulatory requirements for FDA, EMA, PMDA (Japan), GCC regulatory agencies, ICH guidelines, and other global regulatory authorities. Demonstrated ability to develop and execute global CMC regulatory strategies across all phases of product development and commercialization. Strong knowledge of pharmaceutical development, quality systems, process validation, lifecycle management, and global CMC submission requirements. Ability to assess regulatory risks and develop practical, science-based regulatory strategies. Technical Expertise in Small Molecule Drug Product Development Strong technical understanding of small molecule drug product development and manufacturing, including: Oral solid dosage forms (tablets, capsules, coated tablets, modified-release formulations) Formulation development and pharmaceutical development principles Manufacturing processes including blending, granulation, compression, encapsulation, coating, and packaging Scale-up, technology transfer, process validation, and continued process verification Strong understanding of active pharmaceutical ingredient (API) manufacturing considerations, supplier qualification, and regulatory expectations for drug substance and drug product integration. Strong knowledge of analytical development and quality control, including: Method development and validation Dissolution testing Assay and impurity testing Stability-indicating methods Content uniformity and related compendial testing HPLC, UPLC, GC, dissolution, particle size analysis, moisture determination, and other analytical techniques Strong understanding of ICH stability requirements, pharmaceutical quality systems, control strategies, specifications, and lifecycle management. Familiarity with biologics CMC regulatory requirements and development is considered an advantage but is not required. Comp range $132-172K based on experience level #J-18808-Ljbffr