Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

The Associate Director, Regulatory Affairs (Regulatory Intelligence), will be responsible for monitoring, analyzing, and interpreting global regulatory developments to ensure the company’s compliance and strategic positioning in the pharmaceutical market. This role involves collecting and disseminating regulatory information, providing insights to internal stakeholders, and supporting the development of regulatory strategies. Supports the Senior Director, Regulatory Affairs (Labeling/Ad-Promo), in efforts to influence the regulatory environment.

Key Accountabilities

- Proactively monitors and assesses global regulatory environments for emerging changes in laws, regulations, and guidance impacting drug and device development.
- Tracks and evaluates updates from key regulatory authorities (e.g., FDA, EMA), industry associations, and external intelligence sources.
- Maintains and continuously enhances regulatory intelligence databases and tools to ensure accurate, timely, and effective dissemination of information.
- Analyzes regulatory developments, including guidance documents, policies, and regulations,



to determine potential impact on internal processes, development programs, and regulatory strategies. Anticipates and tracks regulatory changes over time, delivering timely, accurate, and actionable updates to impacted stakeholders across the organization.
- Partners with Quality to ensure appropriate change control processes are initiated and tracked through implementation when regulatory changes impact internal procedures.
- Translates complex regulatory information into clear, actionable insights for cross-functional stakeholders.
- Develops and delivers regulatory intelligence communications, including newsletters, alerts, trackers, and periodic reports.
- Responds to internal inquiries by providing tailored regulatory intelligence summaries and detailed analyses to support decision-making.
- Leads and facilitates regulatory intelligence meetings to include review and discussion of ad hoc query requests, regulatory background package requests, health authority guidance, Federal Register notices, public commenting opportunities, newsletter content, training sessions, and knowledge-sharing forums.
- Coordinates cross-functional discussions to evaluate the impact of new or revised regulatory requirements. Collaborates closely with key functions, including Quality, Pharmacovigilance, Clinical, CMC, and Regulatory Affairs,



to ensure alignment and effective implementation.
- Leads the regulatory public commenting process and identifies opportunities to engage with external stakeholders on draft regulations, guidance, and policies.
- Supports the development, coordination, and submission of company comments to regulatory authorities and industry organizations.
- Confirms the list of upcoming regulatory meetings/workshops/conferences remains current.
- Drives continuous improvement of regulatory intelligence processes, systems, and tools to enhance efficiency and value. Authors and conducts periodic review of regulatory intelligence Standard Operating Procedures or work practices.
- Manages and maintains internal knowledge management platforms (e.g., SharePoint, intranet) to ensure accessible and up-to-date information. Develops, reviews and updates the Regulatory Intelligence homepage on the Global Regulatory Affairs Portal.
- Contributes to cross-functional initiatives and organizational projects by providing regulatory intelligence expertise and strategic insight.
- Manages onboarding and offboarding of regulatory intelligence team members and provides input on team member performance. Provides leadership, coaching, and day-to-day oversight for direct reports within Global Regulatory Intelligence, fostering their skilled growth and development.

Position Requirements

Education and Experience:

- Bachelor's degree in life sciences, law, public policy, or a related field.
- A Master's degree or higher is preferred.
- Minimum 8 years’ experience in pharmaceutical regulatory affairs, including 6years’ experience in regulatory intelligence.
- Demonstrates solid working kno

📌 Associate Director, Regulatory Affairs (Australia)
🏢 Telix Pharmaceuticals
📍 Australia