Manager, Regulatory Affairs – CMC

🔥 0 minutes ago

🌐 Canada, United States – Remote

🇨🇦 Canada – Remote 🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

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 and write CMC-specific regulatory dossiers, including 3.2.S and 3.2.P sections • Develop ICH-aligned CMC/technical portions of global regulatory submissions for early- to late-stage and post-approval programs • Plan and prepare or revise eCTD Module 2.3 and Module 3 documents for INDs, IMPDs, NDAs, BLAs, MAAs, CTAs, post-approval supplements, and variation submissions • Ensure regulatory submission accuracy, completeness, and timely delivery • Plan, track, and clearly write Module 3 documentation using regulatory domain systems and processes such as Veeva • Monitor and interpret evolving CMC regulatory requirements, including ICH, US FDA CFRs, EMA Directives, and Annexes • Ensure CMC documentation and data comply with applicable regulations • Collaborate with Quality Assurance, CMC/Manufacturing, and preclinical teams on CMC regulatory scope and 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 • Identify potential CMC regulatory risks and recommend mitigation plans

🎯 Requirements

• Undergraduate degree required • Advanced degree (M.Sc., Ph.D.) 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 CMC regulatory requirements and guidelines, including ICH guidelines and FDA, EMA, and other health authority regulations • Excellent technical writing and verbal communication skills • Ability to communicate complex regulatory issues to internal and external stakeholders • Good analytical and problem-solving skills • 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 Module 3 subsections • Ability to work in a dynamic environment, adjust to changing priorities, and take on new challenges • Commitment to ongoing learning and professional development

🏖️ Benefits

• Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development • Hybrid and remote work arrangements are available across the company

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