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Manager, Regulatory Affairs (CMC)

10 hours, 36 minutes ago
Canada
Full-time
Senior
Technical Writer
Technical Writing and Documentation
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

  • Plan, prepare, and revise eCTD Module 2.3 and Module 3 documents for global regulatory submissions, including INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, supplements, and variations.
  • Author ICH-aligned CMC and technical dossier content for early-stage, late-stage, and post-approval programs.
  • Plan, track, and maintain clear, complete Module 3 documentation using Veeva regulatory systems and processes.
  • Interpret evolving CMC regulations and guidance from ICH, FDA, EMA, and other health authorities to ensure compliant documentation and data.
  • Collaborate with Quality Assurance, CMC/Manufacturing, and preclinical teams to plan and author regulatory content.
  • Assess regulatory implications of manufacturing changes, including site transfers, scale-up, and process changes.
  • Conduct comparability assessments and develop post-approval supplements when needed.
  • Identify CMC regulatory risks and recommend mitigation plans.

Requirements

  • Undergraduate degree required; M.Sc., Ph.D., or other advanced degree in Biological Sciences, Engineering, or a related field preferred.
  • 7+ years of CMC-focused experience in the radiopharmaceutical or biopharmaceutical industry.
  • Strong knowledge of global CMC regulatory requirements, including ICH guidelines and FDA, EMA, and other health authority regulations.
  • Experience authoring CMC regulatory dossiers, including eCTD Module 2.3 and Module 3 sections.
  • Ability to summarize pharmaceutical manufacturing, method-development reports, and data for Module 3 subsections.
  • Excellent technical writing and verbal communication skills for conveying complex regulatory issues to internal and external stakeholders.
  • Strong analytical, problem-solving, and regulatory risk-assessment abilities.
  • Ability to collaborate effectively across functions and geographies in a changing environment.
  • Commitment to ethical conduct, inclusion, continuous learning, and delivering results.

Benefits

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

Interested in this position?

Apply directly on the company website

Apply Now

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