Full-Time Technical Regulatory Writer

Telix Pharmaceuticals is a rapidly growing radiopharmaceutical company seeking an experienced Technical (CMC) Writer in Regulatory Affairs. This role supports the international rollout of our prostate cancer imaging agent and advances our clinical-stage oncology and rare disease products.

Key Responsibilities:

• Lead the compilation, writing, and editing of high-quality Module 3 documents.
• Develop and update SOPs, processes, templates, style guides, and manuals.
• Maintain knowledge of the Telix development pipeline.
• Prepare, review, and edit regulatory submission documents (INDs, NDAs, BLAs, CTDs).
• Ensure compliance with regulatory guidelines and company standards.
• Lead and manage multiple projects, ensuring timely delivery.
• Coordinate with cross-functional teams.
• Conduct thorough document reviews.
• Collaborate with clinical development teams.
• Provide medical writing expertise and support.
• Mentor junior medical writers and oversee contractors.
• Stay current with industry trends.
• Support regulatory submissions and address health authority comments.

Qualifications:

• Bachelor's degree in a scientific field; MS or PhD preferred.
• 5+ years technical/CMC writing experience; 2+ years in Regulatory CMC.
• Experience overseeing and mentoring contractors.
• Strong understanding of drug development, regulations (CFR, FDA, EMA, ICH), and scientific principles.
• Proficiency with document templates, toolbars, and version control.
• Strong project management and communication skills.
• Strong attention to detail.

Key Capabilities:

• Strong communication skills: Able to communicate effectively with colleagues and stakeholders using clear and concise language.

Benefits: Competitive salaries, bonuses, equity program, generous vacation, wellness days, and development support.

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