Senior Regulatory Affairs Specialist

Job Summary

To ensure compliance with regulations and customer expectations, the full-time Senior Regulatory Affairs Specialist will develop and implement programs, manage regulatory submissions, and represent the company in external regulatory discussions while working remotely on an 18+ month contract.

Key responsibilities

• Develop and implement processes to ensure product safety and compliance with regulations
• Prepare document packages for regulatory submissions and maintain updated regulatory information
• Manage regulatory inquiries and represent the company in external regulatory bodies

Required qualifications

• Bachelor's or master's degree or equivalent
• Regulatory experience in a highly regulated industry such as pharmaceuticals or diagnostics
• Typically, at least 4+ years of relevant experience
• Post-graduate certification and/or license may be required