Regulatory Affairs Manager

Due to the expansion of our operations in Europe we are looking for Regulatory Affairs Manager colleague with active experience in a similar role.

We take special attention to the balance of the work and your private life.

The new colleague will work in the Medical team under direction of Medical Director and/or other designated clinical team members.

Tasks and Responsibilities:

• Take active part in the start-up activities of Clinical trials
• Responsible for coordination of the Regulatory Intelligence procedures and regulatory training in those countries which are allocated to him/her ;
• responsible for regulatory affairs procedure implementations and development;
• RAM is supervising the Local Regulatory Officer activities and ensures the periodic Clinical Trial Regulation File update in the countries allocated;
• Works in the CTIS (Clinical Trial Information System)

Requirements:

• University or college degree in medical or clinical research related discipline, or an acceptable combination of education and experience;
• One to two years of direct work experience in the field of regulatory;
• Confident IT skills;
• Professional level of English
• Effective communication, customer focus, teamwork, time management, motivation to learn and develop