Manager, Regulatory Affairs (Clinical Labeling) - Clinical Labeling

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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