Global Regulatory Affairs - CMC Talent Community

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company seeking a Global Regulatory Affairs - CMC Talent Community member to support the international roll-out of its approved prostate cancer imaging agent and advance its portfolio of late clinical-stage products.

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.

Benefits

• Competitive salaries
• Annual performance-based bonuses
• Equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development