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 11/11/2026full-timeRemote • CanadaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Investigational Medicinal Product (IMP) labeling and regulatory compliance, with a strong focus on GMP, GCP, and international regulatory frameworks. Proven ability to manage labeling processes, collaborate with cross-functional teams, and support clinical trial activities across multiple regions.

Highest-signal resume keywords

Investigational Medicinal Product (IMP) LabelingRegulatory Affairs ExperienceGMP and GCP ComplianceLabeling Management SystemsCross-Functional Collaboration

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Investigational Medicinal Product (IMP) LabelingRegulatory AffairsGMP ComplianceGCP ComplianceLabeling Lifecycle ManagementClinical OperationsVersion ControlChange ManagementMultilingual Labeling VerificationProtocol Development

Soft Skills

Strong CommunicationCollaborationAdaptabilityResilienceContinuous Learning

Tools & Technologies

Microsoft OfficeLabeling Management SystemsVeeva

Industry Keywords

Clinical TrialsEU CTRAnnex VIAnnex 13FDA RequirementsICH GCP Guidelines

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 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

What you’ll need

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

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 are available within the company