Technical (CMC) Writer 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 all documents comply with regulatory guidelines, company standards, and industry best practices.
• Lead and manage multiple regulatory technical writing projects simultaneously.
• Coordinate with cross-functional teams to gather necessary information.
• Conduct thorough reviews of documents for accuracy, consistency, and clarity.
• Work closely with clinical development teams to ensure alignment and accuracy of clinical documents.
• Mentor and train junior medical writers and oversee external contractors.

Requirements

• Bachelor’s degree in a scientific or related field required; MS or PhD preferred.
• 5+ years’ overall experience in technical/CMC writing, 2+ years within Regulatory CMC required.
• Experience overseeing and mentoring contractors and junior team members preferred.
• Strong understanding of drug development and regulations (CFR, FDA, EMA, ICH).
• Experience with document templates and proper 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.