Colorado Regulatory Associate

Job Summary

Supporting regulatory strategy activities, the full-time Colorado Regulatory Associate will manage FDA and Health Canada requirements for labeling and advertising, coordinate regulatory submissions, and collaborate with cross-functional teams in a hybrid work environment.

Key responsibilities

• Partner with Medical Affairs and commercial teams to ensure compliance of promotional materials with FDA and Health Canada regulations
• Coordinate and prepare all regulatory submissions related to labeling and advertising
• Develop and maintain project timelines to ensure timely completion of regulatory deliverables

Required qualifications

• Bachelor's degree in a scientific field preferred
• 1-2 years of experience in the pharmaceutical industry preferred
• Proficiency in Microsoft Office and Adobe Acrobat
• Ability to understand regulatory, technical, and scientific concepts and requirements
• Strong organizational and project management skills