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Manager, Regulatory Affairs (Clinical Labeling)

10 hours, 36 minutes ago
United States
Full-time
Senior
Compliance Manager
Legal
Git
Apply Now
Telix Pharmaceuticals

Telix Pharmaceuticals

Telix Pharmaceuticals is a global biopharmaceutical firm dedicated to the development and commercialization of diagnostic and therapeutic products that utilize targeted radiation, aiming to enhance treatment decisions and provide personalized therapies...

Pharmaceuticals
201-500
Founded 2015
View All Jobs 31

Description

  • Lead the creation, revision, review, approval, maintenance, and calibration of IMP labeling for investigational products.
  • Ensure labeling reflects approved protocols, product characteristics, storage conditions, and country-specific requirements.
  • Ensure compliance with global IMP labeling regulations, GMP, GCP, company policies, and applicable regional requirements.
  • Partner with Regulatory Affairs, Clinical Operations, Quality, and external vendors on labeling development and approvals.
  • Provide labeling expertise during protocol development, study start-up, amendments, and country expansion activities.
  • Coordinate multilingual label translation, verification, artwork review, and approval workflows.
  • Manage version control and change management for IMP labeling documentation.
  • Support required IMP labeling submissions and notifications.
  • Monitor regulatory changes and industry trends, assessing their impact on current and future studies.
  • Support regulatory inspections and audits and serve as the labeling regulatory contact for assigned products.

Requirements

  • Bachelor’s degree in life sciences.
  • At least 5 years of experience in pharmaceutical regulatory affairs, global labeling, clinical, or clinical operations.
  • At least 2 years of experience in investigational medicinal product (IMP) or clinical labeling.
  • Experience supporting clinical-trial IMP labeling across multiple regions and regulatory jurisdictions.
  • Knowledge of IMP lifecycle management.
  • In-depth knowledge of international, national, and regional regulatory and clinical frameworks for IMP labeling.
  • Strong understanding of GMP, GCP, EU Clinical Trial Regulation, Annex VI, Annex 13, and FDA IMP requirements.
  • Proficiency with Microsoft Office and labeling management systems; working knowledge of Veeva is preferred.
  • Strong communication, collaboration, adaptability, problem-solving, and continuous-improvement capabilities.
  • Demonstrated integrity, resilience, inclusive mindset, and commitment to quality.

Benefits

  • Competitive salary.
  • Annual performance-based bonus.
  • Equity-based incentive program.
  • Generous vacation and paid wellness days.
  • Learning and development support.
  • Hybrid and remote work opportunities within a global team.

Interested in this position?

Apply directly on the company website

Apply Now

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