Regulatory Affairs Specialist

Job Summary

A company is looking for a Regulatory Affairs Specialist to manage and coordinate regulatory submission processes.

Key Responsibilities

• Coordinate and prepare documents/packages for regulatory submissions, ensuring accuracy and compliance
• Review, edit, and proofread regulatory documentation to maintain high-quality standards
• Prepare and compile responses to regulatory authorities' questions and maintain regulatory files

Required Qualifications

• Bachelor's degree or equivalent in pharmacy or a related scientific discipline
• Minimum 2 years of regulatory experience, preferably within a healthcare environment
• Solid scientific knowledge with the ability to interpret technical data
• Proficiency in technical systems, including word processing, spreadsheets, and databases
• Experience managing a specific product portfolio within regulatory aspects