Manager, Regulatory Affairs - CMC

Job Summary

Responsible for authoring CMC-specific regulatory dossiers, the full-time Manager, Regulatory Affairs - CMC will develop high-quality global regulatory submissions for radiopharmaceutical and biopharmaceutical products while collaborating with cross-functional teams in a hybrid work environment.

Key responsibilities:

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

Required qualifications:

• Undergraduate degree required; advanced degree in Biological Sciences, Engineering, or related field preferred
• 7+ years of experience focused 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