International Regulatory expert – Registration unit

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 of international authorities.

Key Responsibilities:

• Communicate and coordinate clearly/extensively with authorities, agents and other departments to achieve project goals
• Coordination of registration projects
• Preparing 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 and before a product's release.

Education:

• Master of Science (M.Sc.) 
• Pharma D

Requirements:

• attention to detail
• the 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)
• Knowledge of pharmaceutical regulatory is preferred.