Job Summary :
Lead regulatory affairs activities, provide guidance and support to junior staff, and ensure compliance with regulatory requirements.
Responsibilities :
- Lead regulatory affairs activities for complex projects.
- Provide guidance and support to junior regulatory affairs staff.
- Develop and implement regulatory strategies.
- Collaborate with researchers, scientists, and other stakeholders.
- Conduct regulatory audits and inspections.
Requirements :
- Master’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 leadership, communication, analytical, and problem-solving skills.