Regulatory Affairs (Pre-Approval) Supervisor

• Understanding of Regulatory strategy and documentation requirements
• Act as responsible Regulatory Team member for assigned regulatory projects
• Overall regulatory documentation for DCP, MRP and National applications in line with assigned timelines
• Coach, guide and review deliverables of Regulatory Affairs Officers and Associates.
• Liaise with external Regulatory authorities as required.
• Ensure policies and procedures are properly understood, evaluated and carried out. Make sure modifications are investigated if necessary.
• Liaise with various departments to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration
• Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products
• Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities

• BSc Degree in Pharmacy, Biology or relevant field.
• 5+ years of experience in Regulatory within a Pharmaceutical organization.
• Fluent in English and good MS Office skills
• Strong organization skills, multi-tasking and able to meet deadlines
• Effective communication and relationship management
• Knowledge of EU regulatory guidelines
• Ability to work under pressure, resilience

DEMO