Telix Pharmaceuticals Limited
Telix Pharmaceuticals Limited
501 – 1,000 Employees
BiotechnologyConsultingHealthcare

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company developing and commercializing theranostic radiopharmaceuticals for cancer and rare diseases. Its approach combines targeted imaging with radiation-based treatment to support more informed clinical decisions and personalized care.

The company’s pipeline spans prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers. Telix has secured global regulatory approvals for its lead imaging product, Illuccix®, and continues to advance a broad program of clinical trials worldwide. Its team works across healthcare, biotechnology, and related commercial disciplines to bring radiopharmaceutical innovations from development into clinical use.

Associate Director, Regulatory Affairs – Regulatory Intelligence (Remote, United States)

Lead regulatory intelligence activities for Telix Pharmaceuticals across global drug and device development. Deliver regulatory insights, communications, and cross-functional support for pharmaceutical programs.

Description

  • Monitor and interpret global regulatory changes relevant to drug and device development
  • Follow updates from health authorities, industry groups, and external intelligence sources
  • Maintain and improve regulatory intelligence databases and related tools
  • Assess regulatory guidance, policies, and regulations, then communicate their practical effects to stakeholders
  • Collaborate with Quality on change control activities
  • Convert complex regulatory information into clear, actionable insights
  • Create newsletters, alerts, trackers, and recurring regulatory reports
  • Prepare targeted regulatory intelligence analyses to support internal questions and decisions
  • Facilitate regulatory intelligence meetings and knowledge-sharing sessions
  • Coordinate discussions across Quality, Pharmacovigilance, Clinical, CMC, and Regulatory Affairs
  • Lead public consultation responses and support submissions to regulators and industry organizations
  • Keep records of regulatory meetings, workshops, and conferences
  • Enhance regulatory intelligence processes, systems, tools, SOPs, and operating practices
  • Administer internal knowledge resources, including SharePoint, the intranet, and the Global Regulatory Affairs Portal
  • Provide regulatory intelligence support for cross-functional initiatives and company projects
  • Oversee onboarding and offboarding while coaching and managing direct reports day to day

Requirements

  • Bachelor’s degree in life sciences, law, public policy, or a related discipline
  • A master’s degree or higher is preferred
  • At least eight years of pharmaceutical regulatory affairs experience, including six years focused on regulatory intelligence
  • Strong working knowledge of drug, biologic, and device development, including applicable laws, regulations, and FDA, EMA, PMDA, ICH, and other guidelines
  • Familiarity with key regional and global industry association priorities, including PhRMA, EFPIA, and JPMA
  • Proficiency with regulatory intelligence databases and tools
  • Experience engaging with the FDA or other health authorities is preferred
  • Demonstrated analytical, critical-thinking, problem-solving, and decision-making abilities
  • Capacity to work effectively both independently and with colleagues
  • Careful attention to detail and the ability to manage competing priorities
  • Clear communication, adaptability, ethical conduct, and dedication to ongoing learning

Benefits

  • Competitive compensation
  • Annual bonuses tied to performance
  • Equity incentive program
  • Generous vacation allowance
  • Paid wellness days
  • Learning and development support
  • Hybrid and remote working options

Related Jobs