The Senior Director, Regulatory CMC provides strategic leadership for global Chemistry, Manufacturing, and Controls (CMC) regulatory strategy across radiopharmaceutical development programs and future commercial products.Reporting to the Senior Vice President, Global Regulatory Affairs, this role is responsible for defining and executing CMC regulatory strategies, authoring and overseeing Module 3 and Quality sections of regulatory submissions, and leading health authority interactions related to CMC, radiochemistry, and manufacturing.As the company’s senior regulatory CMC expert, this individual partners closely with Manufacturing, Quality, Clinical Development, and Technical Operations to ensure CMC readiness across all stages of development. The role requires deep technical expertise in radiopharmaceuticals (including alpha-emitting radionuclides) radiochemistry, isotope supply considerations, aseptic manufacturing, analytical control strategies, and peptide-based products, and the ability to translate complex regulatory expectations into clear, actionable guidance for cross-functional teams.Essential FunctionsCMC Regulatory LeadershipServe as the global head of Regulatory CMC, with accountability for CMC regulatory strategy across the portfolio.Define and drive forward-looking CMC regulatory strategies to support clinical development, registration, and lifecycle management of radiopharmaceutical products.Provide expert guidance on global regulatory expectations for CMC, particularly for radiopharmaceuticals, including alpha emitters, isotope lifecycle considerations, novel modalities.Act as the primary regulatory advisor to Manufacturing, Technical Operations, and Clinical teams on CMC-related development decisions.Drive CMC regulatory planning, timelines, and risk assessments to support major development, submission, and lifecycle milestones.CMC Strategy & ExecutionLead development, authorship, and oversight of Module 3 (Quality) content and CMC sections of global regulatory documents, including: INDs / CTAs / IMPDsBriefing documents and health authority background packagesNDA / MAA submissions and lifecycle updatesEnsure CMC documentation is scientifically robust, compliant, and aligned with clinical and manufacturing strategy.Partner with cross-functional teams to ensure CMC readiness for regulatory milestones, including clinical trial initiation, Phase transitions, and commercialization.Provide leadership on regulatory approach for CMC changes, comparability assessments, process changes, site transfers, and manufacturing evolution across development and commercialization.Provide regulatory leadership on radiopharmaceutical-specific CMC topics, including radionuclide sourcing, isotope supply, radiochemistry controls, aseptic processing, product release strategy, specifications, and analytical methods for radioactive products.Partner with Manufacturing and Quality to assess the regulatory impact of deviations, investigations, change controls, and other quality events that may affect regulatory filings or commitments.Health Authority Engagement (CMC Focus)Lead preparation and execution of CMC-related regulatory interactions with global health authorities (e.g., FDA, EMA).Serve as the primary CMC subject matter expert in meetings, including: Type B and Type C meetingsScientific advice and regulatory consultationsGuide cross-functional teams on effective engagement with regulatory agencies, including meeting strategy, messaging, and response preparation.Ensure consistent, clear, and technically credible communication of CMC topics across all regulatory interactions.Lead content development for CMC-related briefing materials, responses to agency questions, deficiency letters, and post-submission issue management.Support regulatory preparedness for inspections, pre-approval activities, and manufacturing/site-related agency interactions, as applicable.Cross-Functional IntegrationPartner closely with Manufacturing, Quality, Clinical Development, and Clinical Pharmacology to ensure alignment between CMC strategy and clinical program needs.Provide input into clinical development plans where CMC constraints, radiochemistry, or supply considerations impact study design or execution.Support integration of CMC considerations into broader regulatory and development strategies.Collaborate closely with internal and external manufacturing partners, including CDMOs, testing laboratories, and radionuclide suppliers, to support aligned and inspection-ready CMC regulatory execution.Regulatory Intelligence & Technical ExpertiseMaintain deep expertise in evolving global regulatory frameworks related to: Radiopharmaceuticals and alpha emittersPeptide-based therapeuticsManufacturing controls, radiochemistry, and analytical methodsProactively assess regulatory trends and emerging expectations, translating them into actionable recommendations for internal teams.Serve as a technical and regulatory resource for complex CMC issues, risk assessment, and problem-solving.Monitor evolving global expectations for radiopharmaceutical development and commercialization, including manufacturing controls, sterility assurance, comparability, and lifecycle change management.Team Leadership & Capability BuildingProvide leadership, mentoring, and technical oversight to Regulatory CMC staff and broader regulatory contributors.Build and scale Regulatory CMC capabilities, including processes, standards, and best practices.Lead and oversee external regulatory consultants and vendors supporting CMC activities.QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below
