Job Summary :
Ensure compliance with regulatory requirements for clinical trials, research studies, and medical devices.
Responsibilities :
- Review and interpret regulatory guidelines and laws.
- Prepare and submit regulatory documents to authorities.
- Coordinate with researchers, scientists, and other stakeholders.
- Conduct regulatory risk assessments and develop mitigation strategies.
- Monitor and report changes in regulatory requirements.
Requirements :
- Bachelor’s degree in life sciences, pharmacy, or a related field.
- Proven experience in regulatory affairs, preferably in a medical research center.
- Knowledge of regulatory guidelines and laws (e.g., FDA, EMA, ICH).
- Excellent communication, analytical, and problem-solving skills.