Regulatory Affairs Manager

Key responsibilities:

• Liaise with regulatory agencies and provide appropriate responses to requests from regulatory agencies
• Implement and comply with the requirements of the quality management system in the processes: self-inspection, deviation management, CAPA management
• Provide legal support for GMP inspection
• Ensure timely submission and approval of registration dossiers, registration confirmations and amendments to registration dossiers according to prescribed plans
• Participate in appropriate training to improve knowledge and professional skills
• Take charge of developing and updating written standards

Requirements:

• Postgraduate or graduate in pharmacy/biology/chemistry with considerable experience in Regulatory Affairs with managerial responsibilities
• Additional education in management is beneficial
• Knowledge of drug development process and laws, regulations and practices affecting the pharmaceutical industry
• Fluent written and speaking English
• Experience in people management; team-building and team-working skills