Objective
Reporting to the Senior Vice President, Global Regulatory Affairs, the Executive Director, Global Regulatory Lead (GRL) provides strategic regulatory leadership across radiopharmaceutical clinical development programs and future commercial launches. This role is responsible for the development and execution of global regulatory strategies, as well as for leading global regulatory submissions in support of clinical development, product registrations, and lifecycle management activities.
As the primary regulatory strategic advisor and a core member of cross‑functional development teams, the Executive Director and GRL translates complex and evolving global regulatory requirements into clear, actionable strategies that enable efficient decision‑making and timely execution. The role ensures regulatory alignment across functions, drives key regulatory deliverables, and supports the successful advancement of radiopharmaceutical programs from early development through commercialization in a dynamic regulatory landscape.
Essential Functions
Leadership
- Serve as the single point of accountability for the execution of global regulatory strategy for assigned development programs.
- Develop, maintain, and continuously refine a forward‑looking global regulatory roadmap, integrating companion diagnostic considerations (as applicable), clinical development, CMC/radiochemistry, non‑clinical strategy, quality, manufacturing readiness, and full lifecycle planning.
- Shape and advance innovative global regulatory pathways, including the strategic use of expedited programs, dose and regimen optimization frameworks, incorporation of radiopharmaceutical‑specific guidance, and intentional sequencing of regulatory interactions and scientific advice.
- Drive global regulatory strategy across the entire product lifecycle, including initial approvals, post‑marketing commitments, pediatric development, label expansion, and global market expansion.
- Lead, mentor, and develop Global Regulatory Affairs (GRA) team members, while providing strong matrix leadership across global regulatory contributors and cross‑functional partners.
Program Leadership & Collaboration
- Oversee the planning, authoring, execution, and approval of major global regulatory submissions and health authority interactions for radiopharmaceutical products, including:
- IND, CTA, and CTIS submissions
- Expedited regulatory programs and special designations (e.g., Fast Track, Breakthrough Therapy, PRIME, Orphan Drug Designation)
- Formal regulatory milestone meetings and scientific advice interactions across development phases
- NDA and MAA submissions
- Pediatric plans (iPSP, PIP), IND amendments, and periodic safety updates
- Ensure regulatory submissions are scientifically robust, strategically aligned, and compliant with global regulatory expectations, with particular attention to the unique requirements of radiopharmaceuticals (e.g., manufacturing controls, isotope supply, dosimetry, and integrated safety considerations).
- Lead and coordinate responses to global regulatory inquiries and health authority questions, ensuring scientific rigor, regulatory consistency, and alignment with overall program strategy.
Health Authority Engagement
- Lead the regulatory strategy, content development, and execution for interactions with global health authorities, ensuring integrated, consistent, and scientifically aligned messaging across clinical, CMC/radiochemistry, non‑clinical, dosimetry, and safety topics.
- Drive global regulatory alignment through parallel or coordinated engagement strategies, including joint or sequential scientific advice and milestone interactions with multiple health authorities.
- Serve as a senior regulatory representative and spokesperson for the company in engagements with global health authorities, building credibility and fostering constructive, solution‑oriented regulatory relationships.
Regulatory Intelligence
- Maintain deep expertise in global regulatory frameworks, emerging guidance, and evolving expectations, with particular focus on radiopharmaceutical‑specific considerations (e.g., radionuclidic and radiochemical impurities, dosimetry methodologies, dose optimization, manufacturing controls, and integrated safety assessment).
- Proactively assess the impact of regulatory changes, new guidance, and precedent decisions on radiopharmaceutical development programs, ensuring regulatory strategies remain current, anticipatory, and forward‑looking.
- Translate regulatory intelligence into actionable insights to inform development strategy, risk management, and decision‑making across the portfolio.
Documentation & Quality
- Ensure high‑quality, consistent, and compliant regulatory documentation across global submissions, maintaining alignment with applicable global standards and expectations for radiopharmaceutical products.
- Partner closely with Regulatory Operations to enable efficient submission planning, publishing, tracking, lifecycle management, and archival across regions.
- Oversee alignment of IMPD and CMC module content with radiopharmaceutical clinical supply strategy, radiochemistry readiness, analytical methods, stability programs, and isotope lifecycle considerations.
- Provide strategic oversight and direction to external regulatory consultants, CROs, and specialized vendors, ensuring high‑quality execution, regulatory compliance, and alignment with overall program objectives.
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 or life sciences discipline required; advanced degree (M.S. or Ph.D.) in biology, chemistry, pharmaceutical sciences, engineering, or a related field strongly preferred. Regulatory Affairs Certification (RAC) is a plus.
- Minimum of 10 years of progressive Regulatory Affairs experience within oncology, specialty therapeutics, and/or complex modalities, with demonstrated regulatory leadership and successful global development outcomes.
- Demonstrated experience supporting radiopharmaceutical, oncology, or other complex drug modalities, with a strong understanding of modality‑specific regulatory considerations and the ability to translate evolving guidance into effective development strategies.
- Proven track record of leading major global regulatory submissions and approvals, including INDs, CTAs, and marketing applications, for clinical‑stage and/or commercial products.
- Extensive experience engaging with global health authorities (e.g., FDA, EMA, and other international agencies), serving as a strategic regulatory representative in complex oncology development programs
Knowledge / Skill / Ability
- Strong understanding of global regulatory requirements applicable to oncology and complex therapeutic modalities, with demonstrated ability to apply evolving regulatory frameworks to radiopharmaceutical development.
- Broad knowledge of drug development, regulatory compliance, commercialization, and lifecycle management, with experience operating across early‑ and late‑stage programs.
- Strategic, enterprise‑minded leader with the ability to integrate scientific, regulatory, and business considerations into clear, executable regulatory strategies in an evolving therapeutic landscape.
- Proven ability to lead, influence, and align cross‑functional teams and senior stakeholders within a highly matrixed, global organization.
- Demonstrated project and program leadership skills, with the ability to manage multiple priorities, timelines, dependencies, and risks effectively.
- Proactive, solution‑oriented problem solver who anticipates regulatory and development risks and drives practical, forward‑looking mitigation strategies.
- Clear, credible, and transparent communicator capable of distilling complexity, framing trade‑offs, and influencing executive‑level decision‑making.
- Collaborative and relationship‑driven leader who builds trust and alignment across functions and external partners.
- Comfortable operating with ambiguity and rapid change in a fast‑paced, growth‑stage organization and emerging regulatory environment.
- Demonstrates accountability and ownership, serving as the end‑to‑end steward of the regulatory pathway for assigned assets.
- Ability to travel for business as required (up to 20%).
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- 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.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.