Manager, Regulatory Affairs – Clinical Labeling

Telix Pharmaceuticals Limited

. Lead the creation, revision, review, agreement, and maintenance of Investigational Medicinal Product (IMP) and Calibration Labeling .

Posted 9/30/2026full-timeRemote • United States, Canada, France, Germany, SpainMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Investigational Medicinal Product (IMP) labeling, regulatory compliance, and lifecycle management across multiple regions. Proficient in coordinating labeling processes, managing documentation, and supporting clinical trials while ensuring adherence to international regulatory standards.

Highest-signal resume keywords

Investigational Medicinal Product (IMP) LabelingRegulatory ComplianceGMP and GCP KnowledgeLabeling Management SystemsMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Investigational Medicinal Product (IMP) LabelingRegulatory ComplianceGMP KnowledgeGCP KnowledgeIMP Lifecycle ManagementClinical Trial SupportVersion ControlChange ManagementMultilingual Labeling CoordinationArtwork Review

Soft Skills

Strong CommunicationCollaborationAdaptabilityResilienceContinuous Learning

Tools & Technologies

Labeling Management SystemsMicrosoft OfficeVeeva

Industry Keywords

Clinical OperationsRegulatory AffairsClinical TrialsEU CTRFDA IMP RequirementsAnnex VIAnnex 13Quality AssuranceContract Research OrganizationsContract Manufacturing Organizations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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