Manager, Global Regulatory Affairs

Job Summary

To support the international roll-out of approved cancer imaging agents, the full-time Manager, Global Regulatory Affairs will author CMC-specific regulatory dossiers and ensure compliance with global regulatory requirements while collaborating with cross-functional teams in a hybrid work environment.

Key responsibilities:

• Plan, prepare, and revise eCTD Module 2.3 & Module 3 documents for various regulatory submissions, ensuring accuracy and completeness
• Ensure Module 3 documentation is well-organized, clearly written, and compliant with regulatory standards using relevant systems
• Stay updated on evolving CMC regulatory requirements and provide assessments for manufacturing changes and potential risks

Required qualifications:

• Undergraduate degree required; advanced degree (M.Sc., Ph.D.) in Biological Sciences, Engineering, or a related field preferred
• 7+ years of experience focusing on CMC in the radiopharmaceutical or biopharmaceutical industry
• Solid understanding of global regulatory requirements and guidelines for CMC, including ICH and FDA regulations
• Excellent technical writing skills with the ability to communicate complex regulatory issues effectively
• Strong analytical skills to assess and mitigate regulatory risks