Global Regulatory Affairs - CMC Talent Community

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. We create products aimed at improving the quality of life for people living with cancer and rare diseases. You will support the international roll-out of our approved prostate cancer imaging agent and advance our portfolio of late clinical-stage products addressing significant unmet needs in oncology and rare diseases.

About the role

The Global Regulatory CMC team authors CMC-specific regulatory dossiers (3.2.S and 3.2.P sections) for the development and commercialization of radiopharmaceutical and biopharmaceutical products. This role requires a strong understanding of technical (Quality/CMC) regulatory requirements and the ability to write technical Module 3 dossiers. The team develops ICH-aligned CMC/technical portions of global regulatory submissions that are high-quality, fit for purpose, and prepared in a timely manner for early to late-stage and post-approval programs.

Responsibilities

• Plan, prepare, and revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements, and variation submissions, ensuring accuracy and completeness.
• Ensure Module 3 documentation is planned, tracked, clearly written, and managed using regulatory domain systems (Veeva) and processes.
• Stay current with and interpret evolving CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives, and Annexes. Ensure CMC documentation and data comply with regulations.
• Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams, to plan and author CMC regulatory content.
• Provide regulatory assessments for manufacturing changes, including site transfers, scale-up activities, and process changes. Conduct comparability assessments and develop post-approval supplements as needed.

Requirements

• Undergraduate degree required; advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering, or a related field preferred.
• Experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry.
• Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations.
• Excellent technical writing and verbal communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders.
• Good analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks.
• Ability to work collaboratively and build effective relationships across functions and geographies.
• Skilled at summarizing pharmaceutical manufacturing and method development reports and data into appropriate sub-sections of Module 3.

Benefits

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

Telix offers hybrid and remote work opportunities for employees located around the world. We foster an engaged and supportive team environment with a shared purpose: helping people with cancer and rare diseases live longer, better-quality lives.