Overview

As a regulatory agent, you are responsible for communicating with international partners regarding product submission, pharmacovigilance, complaints and recall management, artwork design, and inspection by international authorities.

Key Responsibilities

• Communicate and coordinate clearly and extensively with authorities, agents, and other departments to achieve project goals.
• Coordinate registration projects.
• Prepare technical and scientific content for regulatory documents.
• Keep up to date with national and international legislation, guidelines, and customer practices.
• Prepare submissions of variations and renewals to strict deadlines.
• Undertake and manage regulatory inspections.
• Take part in the development of marketing concepts and packaging, and in registration projects before a product's release.

Requirements

• Attention to detail.
• Ability to work under pressure and to strict deadlines.
• Good time management.
• Demonstrated passion for excellence and continuous improvement.
• A proactive approach to problem solving.
• English proficiency at least upper-intermediate (B2).
• Basic knowledge of pharmaceutical regulatory affairs.