Manager, Regulatory Affairs – Clinical Labeling

🔥 15 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 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

• 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 applicable local and regional laws, regulations, GMP, GCP, company policies, EU CTR, Annex VI, EU GMP Annex 13, FDA requirements, and ICH GCP guidelines • Provide labeling expertise during protocol development, clinical study start-up, amendments, and country expansion activities • Coordinate translation activities, multilingual labeling verification, artwork review, and approval • Manage version control and change management for IMP documentation • Support IMP labeling submissions and notifications where required • Evaluate new regulatory requirements and industry trends and assess their impact 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 • Improve labeling processes through standardized templates, checklists, workflows, best practices, and tools • Assist with other clinical or commercial labeling activities and special projects as assigned

🎯 Requirements

• Bachelor's degree in life sciences • Minimum 5 years’ experience in pharmaceutical regulatory affairs, global labeling, clinical, or clinical operations • At least 2 years 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, ethical behavior, 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 are available within the company

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