Senior Director, Regulatory CMC

Essential Functions

• CMC Regulatory Leadership
• Serve 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 & Execution
• Lead development, authorship, and oversight of Module 3 (Quality) content and CMC sections of global regulatory documents, including: INDs / CTAs / IMPDs, briefing documents and health authority background packages, NDA / MAA submissions and lifecycle updates.
• Ensure 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 meetings, scientific advice and regulatory consultations.
• Guide 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 Integration
• Partner 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 Expertise
• Maintain deep expertise in evolving global regulatory frameworks related to: Radiopharmaceuticals and alpha emitters, Peptide-based therapeutics, Manufacturing controls, radiochemistry, and analytical methods.
• Proactively 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 Building
• Provide 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.

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree (PhD, MS, or equivalent) in chemistry, pharmaceutical sciences, radiochemistry, or related field strongly preferred.
• Minimum of 12+ years of progressive Regulatory Affairs experience, with significant focus on CMC regulatory strategy and submissions.
• Significant hands-on experience in radiopharmaceutical CMC regulatory affairs is required, including support for radiochemistry, manufacturing controls, and quality strategy for clinical and/or commercial programs. Experience with alpha-emitting radiopharmaceuticals and peptide-based products is strongly preferred.
• Demonstrated success leading CMC sections of major global regulatory submissions, including INDs, CTAs/IMPDs, and marketing applications.
• Extensive experience interacting with global regulatory agencies (e.g., FDA, EMA), including leading preparation for and participation in formal meetings (e.g., Type B, Type C).
• Strong experience working cross-functionally with Manufacturing, Technical Operations, and Quality organizations.
• Experience with CMC change management, comparability, site transfers, technical transfers, and/or commercialization readiness strongly preferred.
• Experience working with internal and external manufacturing networks, including CDMOs and contract testing laboratories, strongly preferred.
• Strong working knowledge of radiopharmaceutical-specific CMC considerations, including isotope supply, shelf-life constraints, aseptic manufacturing, release strategy, specifications, and analytical control of radioactive products.
• Ability to assess and communicate regulatory risk associated with manufacturing changes, quality events, and development-stage process evolution.
• Deep technical and regulatory expertise in CMC for complex modalities, particularly radiopharmaceuticals.
• Strong understanding of global regulatory requirements related to manufacturing, quality, and radiochemistry.
• Proven ability to lead and influence cross-functional teams and senior stakeholders.
• Strong communication skills, with the ability to clearly translate complex technical concepts into regulatory strategy and guidance.
• Experienced in preparing teams for health authority interactions, including coaching on messaging and engagement approach.
• Strategic thinker with strong problem-solving skills and ability to anticipate regulatory and development risks.
• Collaborative, relationship-driven leader with strong interpersonal and influencing skills.
• Comfortable operating in a fast-paced, evolving development environment.
• Demonstrates ownership and accountability for CMC regulatory outcomes across the portfolio.
• Ability to travel as needed (up to ~20%).