Telix Pharmaceuticals Limited
Biotechnology • Pharmaceuticals • Healthcare Insurance
Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.
Senior Manager, Global Regulatory Affairs – CMC
November 24
Telix Pharmaceuticals Limited
Biotechnology • Pharmaceuticals • Healthcare Insurance
Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.
📋 Description
• Author/write CMC specific regulatory dossiers for radiopharmaceutical and biopharmaceutical products • Plan, prepare/revise eCTD Module 2.3 & 3 documents for various submissions • Ensure Module 3 documentation is clearly written and compliant with regulations • Stay current on evolving CMC regulatory requirements and guidelines • Collaborate with internal stakeholders for regulatory scope and content planning • Provide assessments for manufacturing changes and develop post-approval supplements • Identify CMC regulatory risks and suggest mitigation plans
🎯 Requirements
• Undergraduate degree required • Advanced degree (M.Sc., Ph.D.) preferred • 9+ years of experience focused on CMC in radiopharmaceutical/biopharmaceutical industry • Solid understanding of global regulatory requirements for CMC • Excellent technical writing and verbal communication skills • Good analytical and problem-solving skills • Ability to work collaboratively across functions • Skilled at summarizing pharmaceutical manufacturing and method development reports into Module 3 subsections
🏖️ Benefits
• Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development
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