Remote Manager, Global Regulatory Affairs Labeling

Summary

Join Telix Pharmaceuticals, a dynamic and fast-growing radiopharmaceutical company, as the Manager, Global Regulatory Affairs Labeling. You will support the international roll-out of our approved prostate cancer imaging agent and help advance our portfolio of late clinical-stage products addressing significant unmet need in oncology and rare diseases.

Requirements

• BA/BS in scientific degree (chemistry, biology, pharmaceutical sciences) required. Advanced degree a plus
• 5+ years’ experience in regulatory affairs labeling for pharmaceuticals products required
• Direct experience in writing Target Product Profiles, Target Labeling, Company Core Data Sheets, and local labeling such as USPIs and/or EU SmPCs
• Experience across product lifecycle (i.e., development to post-marketing)
• Comprehensive knowledge of the drug development process
• Ability to understand and interpret Federal, State and Local regulations and guidance documents as well as common and scientific and technical journals

Responsibilities

• Independently (with little supervision) lead the development, revision, review, and approval of Target Product Profiles, Target Labeling, Company Core Data Sheets, and Local Labeling
• Draft labeling content that is consistent with the company strategy for the product. Collaborate with internal and external colleagues to provide input into labeling documents
• Resolve any labeling issues and coordinate approval by the Labeling Management Team
• Ensure labeling documents are well-supported by other regulatory documentation (e.g., CSRs, Summary of Clinical Efficacy, Summary of Clinical Safety, etc.) in preparation for submission to Health Authorities
• Make recommendations and provide advice and guidance on regulatory documentation to ensure the documents support the labeling
• Draft labeling text for packaging components
• Collaborate with internal and external colleagues on branding, logos, and design of packaging components
• Coordinate artwork creation with manufacturing and supply chain and/or external vendors
• Collaborate with Project Management and Global Regulatory Affairs representatives to define timelines for labeling deliverables and ensure those timelines are met
• Ensure labeling documents are compliant with internal and external templates, internal standards, and external regulations and guidance
• Maintain a high standard of attention to detail with a goal of zero errors in labeling documents meant for a prescriber or patient
• Contribute to the continuous improvement of the end-to-end labeling process

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development