Objective

Essential Functions

• 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.

• 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.

• 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.

• 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.

• 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.

• 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education / Experience

• 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%).

Work Environment

• This is a remote, home-based position, performed primarily in a standard office environment.
• Must be able to work during regular business hours, with flexibility to support meetings across time zones and occasional work outside of standard hours as business needs require.
• Ability to sit for extended periods of time while working at a computer and participating in virtual meetings.
• Ability to use standard office equipment, including a computer, phone, and video conferencing tools.
• Must possess strong attention to detail and the ability to manage information accurately in a virtual work environment.
• Ability to work independently and effectively in a remote, collaborative, and team-based setting.
• Willingness to complete required corporate, compliance, and systems training within established timeframes.

• Occasional travel may be required, consistent with business needs.