Manager - Global Regulatory Affairs, Labeling
October 5
Description
• Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company. • Support the international roll-out of our approved prostate cancer imaging agent. • Help advance our portfolio of late clinical-stage products. • Work within Global Regulatory Affairs and with cross-functional product teams. • Draft and maintain target product profiles (TPPs) and labeling throughout the product lifecycle.
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.
Benefits
• Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development
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