Manager, Regulatory Affairs – CMC

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

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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, for radiopharmaceutical and biopharmaceutical products • Develop ICH-aligned CMC/technical portions of global regulatory submissions for early- to late-stage and post-approval programs • Plan, prepare, and revise eCTD Module 2.3 and 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, accurate, complete, and managed using regulatory systems such as Veeva • Interpret evolving CMC regulatory requirements and guidelines, including ICH, US FDA CFRs, EMA Directives, and Annexes • Collaborate with Quality Assurance, CMC/Manufacturing, and preclinical teams on CMC regulatory scope and content • Provide regulatory assessments for manufacturing changes, site transfers, scale-up activities, and process changes • Conduct comparability assessments and develop post-approval supplements as needed • 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 CMC regulatory requirements and guidelines, including ICH guidelines and FDA, EMA, and other health authority regulations • Excellent technical writing and verbal communication skills • 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 Module 3 subsections • Commitment to excellence, results orientation, creativity and innovation, collaboration, resilience, inclusivity, adaptability, ethical behavior, and continuous learning

🏖️ Benefits

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