Regulaotry Affairs Manager

Budapest
04-07-2024
Job Type
Permanent
Emp Type
Full Time
Functional Expertise
Regulatory Affairs
Salary Type
Annual

Job Description

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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