Manager, Regulatory Affairs – Clinical Labeling

🕒 September 30

🌐 United States, Canada, +3 more countries – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote 🇫🇷 France – Remote 🇩🇪 Germany – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 14%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 46 days.
• Jobs at this company usually fill in 34 days.
• No salary listed.

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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

• Lead the creation, revision, review, agreement, and maintenance of Investigational Medicinal Product (IMP) and Calibration Labeling • Collaborate with Regulatory Affairs, Clinical Operations, Quality, Contract Research Organizations, Contract Manufacturing Organizations, translation vendors, artwork vendors, and packaging vendors • Ensure label content reflects approved protocol requirements, product characteristics, storage conditions, and country-specific requirements • Ensure compliance with local and regional regulations and internal policies across the United States, European Union, United Kingdom, Australia, Canada, Asia-Pacific, and other participating countries • Provide labeling expertise during protocol development, clinical study start-up, amendments, and country expansion • Coordinate translation activities and verification of multilingual labeling content • Coordinate artwork review and approval in the compliance system • Manage version control and change management for IMP documentation • Support IMP labeling submissions or notifications where required • Evaluate new regulatory requirements and industry trends and assess impacts on studies • Support regulatory inspections and audits with IMP documentation and subject matter expertise • Serve as regulatory point of contact for IMP labeling, independently resolving issues and escalating complex matters • Maintain efficient labeling processes using standardized templates, checklists, and workflows • Identify process improvements, best practices, and tools • Assist with other clinical or commercial labeling activities and special projects

🎯 Requirements

• Bachelor's degree in life sciences • Minimum 5 years’ experience in pharmaceutical regulatory affairs, global labeling, clinical, or clinical operations, including at least 2 year of experience in Investigational Medicinal Product (IMP) labeling (“Clinical Labeling”) • Experience supporting IMP (clinical) labeling for clinical trials across multiple regions and regulatory jurisdictions • Knowledge of IMP lifecycle management • In-depth understanding of relevant international, national, and regional regulatory and/or clinical frameworks, processes, and requirements • Strong understanding of GMP, GCP, EU CTR, Annex VI, Annex 13, and FDA IMP requirements • Proficiency with Microsoft Office applications and labeling management systems • Working knowledge of Veeva is desired • Strong communication, collaboration, adaptability, resilience, and continuous-learning capabilities

🏖️ Benefits

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

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