The Manager, Regulatory Affairs (Operations) is responsible for managing, organizing, and delivering regulatory submission documents while ensuring compliant workflows across departments. They will also provide expertise in document preparation, coordinate submission timelines, and maintain regulatory information management systems.
This role provides technical and analytical expertise for late-phase biologics process development and manufacturing activities at external CDMO partners. You will be responsible for managing projects, ensuring regulatory compliance, and contributing to cross-functional collaborations to support clinical and commercial drug substance production.
Support the international roll-out of approved prostate cancer imaging agents. Help advance a portfolio of late clinical-stage products addressing unmet needs in oncology and rare diseases.
Lead legal operations and transformation, including legal technology architecture, contracting infrastructure, AI-enabled workflows, process improvement, and change management. Manage legal operations staff, vendors, budgets, and performance metrics while supporting commercial and procurement contracting and partnering across the business.
The Governance & Securities Specialist provides execution-focused support for U.S. public company governance, SEC/NASDAQ compliance, and Board administration. This role manages regulatory calendars, entity records, and documentation to support senior governance and securities lawyers.
The Salesforce Enablement Analyst will serve as the primary owner of Salesforce operations, governance, and enablement to ensure data integrity and scalable processes. This role involves managing the request intake process, enforcing data quality standards, and partnering with IT to drive platform enhancements.
Build trusted scientific relationships with healthcare professionals and key opinion leaders, and provide accurate, balanced scientific exchange on disease states, clinical data, and Telix products and pipeline assets. Support clinical trials, evidence-generation and education initiatives, document field insights, and collaborate with internal teams while maintaining compliance.
Lead the strategy, design, administration, and continuous improvement of employee benefits programs, ensuring they are competitive, cost-effective, and aligned with workforce needs. Manage a Benefits Specialist, vendors, compliance and regulatory filings, open enrollment, benefits systems, and employee education and engagement.
The CMC Program Lead is responsible for leading the CMC Sub-Team and serving as the single point of contact for all CMC topics for early-stage antibody-conjugate radiopharmaceutical assets. They will develop and execute integrated CMC strategies, manage cross-functional deliverables, and ensure readiness for Stage-Gate requirements from preclinical through phase 3.
The Senior Clinical Project Manager is responsible for the end-to-end execution of national and global clinical trials, including protocol development, budget management, and vendor oversight. They will lead cross-functional teams to ensure study deliverables are met while proactively managing risks and maintaining quality standards.
The Director of CMC Programs will oversee a team of CMC leads to execute manufacturing and operational strategies for commercial and late-stage clinical assets. They will manage relationships with contract manufacturers and coordinate cross-functional efforts to ensure global production and supply chain success.
The Director of CMC Programs will oversee a team of CMC program leads to execute manufacturing and operational strategies for commercial and late-stage clinical assets. This role involves managing relationships with contract manufacturers, coordinating global supply chain activities, and ensuring project goals are met through cross-functional collaboration.
The Clinical Supply Chain Site Lead acts as the primary operational liaison between clinical trial sites, suppliers, and internal stakeholders to ensure uninterrupted patient treatment. This role manages site-level communications, resolves operational issues such as shipment delays or temperature excursions, and drives continuous improvement initiatives.
Lead the implementation and ongoing development of Telix’s global business resiliency program, including continuity planning, crisis and incident management, emergency preparedness, and recovery. Establish governance, accountability, exercises, training, and performance measures while advising senior leaders and partnering across functions and geographies.
The Senior Manager, Clinical Quality will establish and maintain quality assurance processes to ensure clinical trials comply with GCP, GVP, and GCLP standards. They are responsible for planning and conducting audits, managing inspection preparations, and providing quality oversight for clinical development programs.
The Associate Medical Director leads the execution of the US medical affairs plan for the prostate cancer theranostic portfolio, driving cross-functional alignment across clinical, commercial, and regulatory teams. They serve as a subject-matter expert to develop medical strategy, manage KOL relationships, and oversee clinical trial recruitment and medical education initiatives.
The Associate Medical Director leads the execution of the US medical affairs plan for the renal cancer theranostic portfolio, driving cross-functional alignment across clinical, commercial, and regulatory teams. They serve as a subject-matter expert to guide medical strategy, clinical protocol development, and scientific engagement with key opinion leaders.
The Associate Director of Clinical Operations is responsible for the operational planning and execution of clinical studies, ensuring they meet quality, timeline, and budget objectives. They also provide leadership and line management to their team while overseeing CRO/vendor performance and global recruitment strategies.
The Assistant General Counsel serves as the lead legal partner for Americas commercial and medical affairs, overseeing Phase 3 and go-to-market activities. This role involves managing regulatory compliance, promotional review, government pricing, and complex commercial contracting across the product lifecycle.
The Legal Counsel will provide day-to-day legal support for Telix Manufacturing Solutions, focusing on drafting and negotiating manufacturing and supply contracts. The role also involves managing contract disputes, ensuring regulatory compliance, and improving internal contracting workflows.
The CQV Lead provides Quality Assurance oversight for facility construction, equipment qualification, and operational readiness across the manufacturing network. This role partners with cross-functional teams to ensure all validation activities and site transitions comply with cGMP requirements and internal quality systems.
The Principal Scientist leads early-phase biologics process development and manufacturing activities across multiple technology areas including analytical, purification, and bioconjugation. They are responsible for managing internal and external CMC partnerships, ensuring regulatory compliance, and contributing to clinical manufacturing programs.
The Manager, Regulatory Affairs (Clinical Labeling) is responsible for the development, maintenance, and oversight of investigational medicinal product labeling for global clinical trials. This role ensures compliance with global regulatory requirements while partnering with cross-functional teams to support supply chain execution and study timelines.
The Manager, Regulatory Affairs (Ad-Promo) provides strategic and tactical regulatory advice for advertising and promotional materials across global markets. They manage regulatory reviews, coordinate health authority submissions, and ensure compliance with local laws and internal policies.
Drive sales growth across the assigned territory by identifying new business opportunities, executing sales plans, and managing relationships with healthcare clients. Promote radiopharmaceutical products through clinical presentations and training, while tracking sales activity, analyzing performance, and complying with company and regulatory requirements.
The VP of Medical Affairs will define and execute the medical strategy for the Americas, overseeing operations, budget, and tactical execution across the company's oncology portfolio. They will lead a team of Medical Directors and field staff while fostering collaborations with key opinion leaders and internal stakeholders to support clinical trials and product launches.
The Theranostics Specialist will lead the strategic onboarding of new imaging sites and ensure the successful adoption of Telix radiopharmaceuticals. This role involves driving cross-functional collaboration, optimizing site workflows, and executing field activities to support product launches and HCP education.
The Associate Director will lead global regulatory activities for clinical and commercial registrations, managing the PSMA franchise portfolio. This role involves developing regulatory strategies, overseeing submissions, and ensuring compliance across international health authorities.
The Theranostics Specialist will serve as a field-based expert to oversee the strategic onboarding of imaging sites and ensure the successful adoption of Telix radiopharmaceuticals. This role involves driving cross-functional collaboration, optimizing site workflows, and executing field activities to support product launches and HCP education.
The Medical Science Liaison will serve as a field-based expert responsible for scientific exchange and building peer-to-peer relationships with neuro-oncology experts. They will also support clinical trial site engagement, generate actionable medical insights, and deliver scientific presentations to support the neuro-oncology portfolio.
