Senior Associate Regulatory Affairs

Job Summary

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

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 the Global Regulatory Team to support the execution of regulatory strategies

Required qualifications:

• Master's degree in a relevant field, 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