Regulatory Staff
เกี่ยวกับตำแหน่งนี้
The Regulatory Staff position requires a qualified individual to manage regulatory affairs within the pharmaceutical and medical device industry, ensuring compliance with relevant regulations.
หน้าที่รับผิดชอบ
• Manage regulatory documentation and submission.
• Monitor and ensure the registration process follows the set timelines.
• Take initiative and solve potential problems.
คุณสมบัติ
• Bachelor's degree in a pharmacy, chemistry, health science or related field.
• Minimum of 3 years of experience in regulatory affairs within the pharmaceutical and medical device industry.
• Strong knowledge of regulatory requirements, including BPOM, Kemenkes.
• Knowledge of regulatory requirements of FDA, EMA, and regulatory agencies in other countries is preferable.
• Strong understanding of drug regulation and healthcare policies.
• Good communication skills, both verbal and written.
• Project management skills.
• High attention to detail.
• Ability to work within tight deadlines and manage a high workload.
• Fluent in English.