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Telix Pharmaceuticals (AMER)

Manager, Regulatory Affairs (Clinical Labeling)

Canada

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Job details

Posting language: English
Posted: Oct 6, 2026

Original job description

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

The Manager, Regulatory Affairs (Clinical Labeling), is responsible for the development, maintenance, and oversight of Investigational Medicinal Product (IMP) labeling (also referred to as “Clinical Labeling”, “Special Access Scheme labeling”, “Compassionate Use labeling”, “Early Access Program labeling”, etc.) for Telix’s investigational products used in global clinical trials. This role ensures that all IMP labeling complies with applicable global regulatory requirements, Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs), and company standards while supporting supply chain execution and study timelines.

The Manager, Regulatory Affairs (Clinical Labeling), serves as a key cross-functional partner to Regulatory Affairs, Clinical Operations, Quality, and other internal stakeholders and external vendors to develop and manage labeling documents that support investigational products throughout the clinical development lifecycle. Provides strategic direction and operational oversight for IMP labeling activities throughout the product development lifecycle, partnering with the Senior Director, Regulatory Affairs (Labeling/Ad-Promo).

Key Accountabilities:

Leads the creation, revision, review, agreement, and maintenance of Investigational Medicinal Product (IMP) labeling (also referred to as “Clinical Labeling”, “Special Access Scheme labeling”, “Compassionate Use labeling”, “Early Access Program labeling”, etc.) and Calibration Labeling for Telix’s investigational products.
Collaborates with internal stakeholders (e.g., Regulatory Affairs, Clinical Operations, Quality) and external partners (e.g., Contract Research Organizations, Contract Manufacturing Organizations, translation vendors, artwork vendors, packaging vendors) for input, review and approval of IMP labeling.
Ensures label content accurately reflects approved protocol requirements, product characteristics, storage conditions, and country-specific requirements.
Ensures regulatory compliance with applicable local and regional laws and regulations and internal policies governing IMP labeling, including requirements for the United States, European Union, United Kingdom, Australia, Canada, Asia-Pacific, and other participating countries. These requirements include, but are not limited to, EU Clinical Trial Regulation (CTR) and Annex VI requirements, EU GMP Annex 13 requirements, U.S. FDA requirements, ICH GCP guidelines, and country-specific IMP labeling requirements.
Provides labeling expertise during protocol development, clinical study start-up, amendments, and country expansion activities.
Coordinates translation activities and verification of multilingual labeling content.
Coordinates review and approval of artwork for IMP labeling in the compliance system.
Manages version control and change management for IMP documentation in accordance with regulatory expectations.
Supports submission of IMP labeling where submission or notification is required.
Evaluates new regulatory requirements and industry trends impacting IMP labeling; assesses the impact of changing regulations on existing and future studies.
Supports regulatory inspections and audits by providing IMP documentation and subject matter expertise.
Serves as the regulatory point of contact for IMP labeling for assigned products, resolving issues independently and escalating complex matters as appropriate.
Contributes to maintaining efficient IMP labeling processes by using standardized templates, checklists, and workflows.
Identifies process improvements, best practices, and tools to enhance the efficiency and quality of IMP labeling.
Assist with other labeling activities and special projects, whether clinical or commercial in nature, as assigned by management, to support departmental objectives, business priorities, and continuous improvement initiatives.

Position Requirements

Education and Experience:

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

Key Capabilities:

Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR PRIVACY POLICY HERE

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More about this job

Responsibilities

The Manager of Regulatory Affairs (Clinical Labeling) is responsible for the development, maintenance, and oversight of investigational medicinal product labeling for global clinical trials. This role serves as a key cross-functional partner to ensure labeling compliance with global regulatory requirements, GMPs, and GCPs throughout the product development lifecycle.

Requirements

Candidates must hold a bachelor's degree in life sciences and have at least 5 years of experience in pharmaceutical regulatory affairs or clinical operations. A minimum of 2 years of specific experience in investigational medicinal product labeling is required, along with a strong understanding of international regulatory frameworks.

Skills

Regulatory affairs
Clinical labeling
Investigational medicinal product labeling
GMP
GCP
EU CTR
FDA regulations
Lifecycle management
Cross-functional collaboration
Project management
Regulatory compliance
Veeva
Quality assurance
Clinical operations
Documentation management

Benefits

Competitive salary
Annual performance-based bonuses
Equity-based incentive program
Generous vacation
Paid wellness days
Learning and development support

Visa sponsorship

Not detected in the job text

Keywords

Regulatory Affairs
Clinical Labeling
Investigational Medicinal Product
Radiopharmaceutical
Oncology
Rare Diseases
GMP
GCP
EU CTR
FDA
Annex VI
Annex 13
Veeva
Clinical Trials
Quality Assurance
Compliance
Lifecycle Management
Supply Chain
Artwork Management
Translation Coordination
Regulatory Inspections
Protocol Development
Cross-functional Leadership
Strategic Planning
Documentation Control

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