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Manager, Regulatory Affairs (Clinical Labeling)

10 hours, 36 minutes ago
Canada
Full-time
Senior
Compliance Manager
Operations
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, review, approval, maintenance, and revision of IMP and calibration labeling for investigational products.
  • Ensure label content aligns with approved protocols, product characteristics, storage conditions, and country-specific requirements.
  • Partner with Regulatory Affairs, Clinical Operations, Quality, and external vendors to develop and manage labeling documents.
  • Provide labeling expertise during protocol development, study start-up, amendments, and country-expansion activities.
  • Ensure compliance with global IMP labeling regulations, GMP, GCP, internal policies, and applicable regional requirements.
  • Coordinate translations, multilingual-content verification, and artwork review and approval in the compliance system.
  • Manage IMP labeling documentation, version control, and change management.
  • Support required IMP labeling submissions or notifications, regulatory inspections, and audits.
  • Monitor regulatory changes and industry trends, assess their impact, and improve labeling processes, templates, workflows, and tools.
  • Serve as the regulatory point of contact for assigned products and support additional clinical or commercial labeling projects.

Requirements

  • Bachelor's degree in life sciences.
  • Minimum 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 IMP labeling for clinical trials across multiple regions and regulatory jurisdictions.
  • Knowledge of IMP lifecycle management.
  • In-depth understanding of international, national, and regional regulatory and clinical frameworks.
  • Strong knowledge 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 (preferred).
  • Strong communication, collaboration, adaptability, integrity, and continuous-learning mindset.

Benefits

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

Interested in this position?

Apply directly on the company website

Apply Now

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