Regulatory Affairs Manager 

I am collaborating with a leading Central & Eastern European CRO who, due to their expanding operations across Europe, are seeking a Regulatory Affairs Manager with substantial experience in a similar role. The company is recognized for promoting a balanced work-life dynamic and a collaborative work environment, encouraging continuous learning and development for its employees.

Role Overview:

The successful candidate will join the Medical team, reporting directly to the Medical Director or other designated clinical team members.

Key Responsibilities:

• Coordinate Regulatory Intelligence procedures and conduct regulatory training in assigned countries.

• Implement and develop regulatory affairs procedures.

• Supervise the activities of Local Regulatory Officers and ensure periodic updates of the Clinical Trial Regulation File in the assigned countries.

• Operate within the Clinical Trial Information System (CTIS).

• Engage in the start-up activities of clinical trials.

Requirements:

• Strong communication skills, customer focus, teamwork abilities, effective time management, and a motivation to learn and develop

• A university or college degree in a medical or clinical research-related field, or an equivalent combination of education and experience.

• One to two years of hands on experience in regulatory affairs.

• Proficient IT skills.

• Professional proficiency in English.

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