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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 Intelligence – Regulatory Affairs (Remote, Canada)
Lead global regulatory intelligence for Telix Pharmaceuticals, tracking developments that affect drug and device programs. Turn regulatory changes into clear strategies, communications, and coordinated actions across the business.
Description
- Monitor worldwide regulatory landscapes for changes to laws, regulations, and guidance relevant to drug and device development
- Evaluate updates from health authorities, industry groups, and other external intelligence sources
- Administer and improve regulatory intelligence databases and supporting tools
- Assess regulatory developments for their effects on internal processes, development programs, and regulatory strategies
- Provide stakeholders with timely regulatory updates and practical recommendations
- Collaborate with Quality on change-control activities resulting from regulatory changes
- Convert complex regulatory material into concise, actionable guidance
- Create and distribute newsletters, alerts, tracking documents, and recurring reports
- Address internal requests with customized regulatory intelligence briefings and analysis
- Facilitate regulatory intelligence meetings, training, and knowledge-sharing sessions
- Coordinate cross-functional engagement across Quality, Pharmacovigilance, Clinical, CMC, and Regulatory Affairs
- Direct public-comment activities and assist with submissions to health authorities and industry bodies
- Keep regulatory meeting, workshop, and conference calendars current
- Advance regulatory intelligence processes, systems, tools, SOPs, and operating practices
- Oversee knowledge-management platforms, including SharePoint, the intranet, and the Global Regulatory Affairs Portal
- Provide regulatory intelligence input to cross-functional programs and organizational projects
- Oversee team-member onboarding and offboarding while leading, coaching, and supervising direct reports
Requirements
- Bachelor’s degree in life sciences, law, public policy, or a related discipline
- At least eight years of pharmaceutical regulatory affairs experience, including six years focused on regulatory intelligence
- Working knowledge of drug, biologic, and device development, along with FDA, EMA, PMDA, ICH, and other applicable requirements
- Familiarity with priorities of major regional and global industry associations, including PhRMA, EFPIA, and JPMA
- Experience using regulatory intelligence databases and tools
- Strong analytical, critical-thinking, problem-solving, and judgment skills
- Able to work independently with limited direction and contribute effectively within a team
- Highly detail-oriented with the ability to balance competing priorities
- A master’s degree or higher is preferred
- Experience engaging with the FDA or other health authorities is desirable
Benefits
- Annual bonuses tied to performance
- Equity-based incentive program
- Generous vacation allowance
- Paid wellness days
- Learning and development support
- Hybrid and remote work options
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