Manager, Global Regulatory Affairs – CMC

🕒 May 8

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

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

• Authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections) • Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements and variation submissions • Ensure Module 3 documentation is planned, tracked, clearly written • Stay current and interpret evolving CMC regulatory requirements and guidelines • Collaborate with internal stakeholders including Quality Assurance, CMC/Manufacturing, and preclinical teams • Provide regulatory assessments for manufacturing changes • Identify potential CMC regulatory risks and suggest mitigation plans

🎯 Requirements

• Undergraduate degree required; Advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering or a related field preferred. • 7+ years of 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. • Good analytical and problem-solving skills. • Ability to work collaboratively and build effective relationships across functions and geographies. • Skilled at summarizing pharmaceutical manufacturing and method development reports.

🏖️ Benefits

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