Senior Regulatory Operations Specialist

Job Summary

To manage global regulatory submissions, the full-time Senior Regulatory Operations Specialist will coordinate, publish, and maintain dossiers while working remotely with cross-functional teams and external providers to ensure compliance and timely delivery.

Key Responsibilities

• Lead the operational delivery of global regulatory submissions across various lifecycle stages
• Maintain accurate regulatory information and submission records in approved systems
• Support inspection readiness and process improvement initiatives while utilizing AI and automation tools

Required Qualifications

• Bachelor's degree in life sciences, information management, technology, or a related field
• 6 to 8 years of regulatory experience in pharmaceutical or biotechnology sectors, with a focus on Regulatory Operations
• 3 years of experience in electronic submission publishing and technical dossier management
• Experience with global submissions, particularly in the U.S. and Europe
• Familiarity with regulatory information management and electronic document management systems