Senior Associate Regulatory Affairs

Job Summary

A company is looking for a Senior Associate - Regulatory Affairs.

Key Responsibilities

• Coordinate and execute US regulatory submissions in compliance with corporate standards
• Manage the preparation, delivery, and archiving of documentation for US regulatory submissions
• Assist in managing Global Regulatory Team interactions and support local regulatory activities

Required Qualifications

• Master's degree or Bachelor's degree with 2 years of Regulatory Affairs experience
• Associate's degree with 6 years of Regulatory Affairs experience, or a high school diploma/GED with 8 years of experience
• Experience in regulatory documentation and compliance
• Ability to collaborate with external partners and manage multiple activities
• Experience with regulatory submissions and agency communications