Technical Regulatory Writer (CMC) in Regulatory Affairs - Remote

Overview

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.

In Short

• Lead the compilation, writing, and editing of high-quality module 3 documents.
• Develop and update pertinent SOPs, processes, templates, style guides, and manuals.
• Maintain working knowledge of the Telix development pipeline.
• Prepare, review, and edit regulatory submission documents (e.g., INDs, NDAs, BLAs, CTDs).
• Ensure compliance with regulatory guidelines and company standards.
• Manage multiple regulatory technical writing projects simultaneously.
• Coordinate with cross-functional teams for document development.
• Conduct thorough reviews of documents for accuracy and clarity.
• Provide medical writing expertise to project teams.
• Mentor and train junior medical writers.

Requirements

• Bachelor’s degree in a scientific or related field required; MS or PhD preferred.
• 5+ years’ experience in technical/CMC writing, 2+ years in Regulatory CMC.
• Experience overseeing and mentoring contractors preferred.
• Strong understanding of drug development and regulations.
• Proficiency with document templates and version control.
• Strong project management skills and attention to detail.

Benefits

• Competitive salaries and annual performance-based bonuses.
• Equity-based incentive program.
• Generous vacation and paid wellness days.
• Support for learning and development.