Senior Associate Regulatory Affairs

Job Summary

Assisting the US Regulatory Leads, the full-time Senior Associate Regulatory Affairs will coordinate and execute US regulatory submissions, manage documentation for regulatory compliance, and support Global Regulatory Team interactions in a remote capacity.

Key responsibilities include:

• Assist US Regulatory Lead with local regulatory activities, including IND submissions and agency meetings
• Manage the preparation and archiving of documentation for US regulatory submissions
• Collaborate with CROs and partners to support site initiation and regulatory compliance

Required qualifications:

• Master's degree, or Bachelor's degree with 2 years of Regulatory Affairs experience, or Associate's degree with 6 years of experience, or High school diploma/GED with 8 years of experience in Regulatory Affairs