Regulatory Affairs Consultant

Job Summary

A company is looking for a Regulatory Affairs Specialist - Consultant.

Key Responsibilities

• Review new certificate requests and manage submissions to FDA
• Project manage multiple requests to ensure deadlines are met and maintain communication with stakeholders
• Support continuous improvement of regulatory processes and deliver product license maintenance portfolio

Required Qualifications

• 3+ years of regulatory experience
• Experience with US Annual Report submissions
• Demonstrated ability to support international product approval
• Bachelor's degree or equivalent work experience
• Familiarity with pharmaceutical organizational structures