Qualification and Competency Requirements for API Registrars:

　　1. Bachelor's degree or above in Pharmacy or Pharmaceutical Analysis.

　　2. Obtain CET-6 or above certificate; graduates majoring in pharmaceutical foreign languages are exempt from English proficiency restrictions.

　　3. Possess strong learning ability, able to quickly familiarize with CFDA/ICH/FDA/EMEA guidelines, and have good English listening, speaking, reading, and writing skills.

　　4. Must have a strong sense of responsibility, good communication skills, ability to work independently, teamwork skills, and learning ability.

　　5. After a six-month probation period, be able to review research documents submitted for DMF preparation under system training to ensure compliance with technical requirements of various registration countries.

　　Responsibilities of API Registrars:

　　1. Able to prepare API registration documents according to the requirements of various registration countries (non-mainstream countries and domestic); ensure all submitted materials comply with relevant regulations and technical guidelines to facilitate smooth approval of registration applications.

　　2. Able to submit applications timely according to drug registration procedures and comply with the registration work procedures of drug regulatory authorities; handle related formalities in a standardized manner.

　　3. API registrars need to prepare relevant drug registration application materials under the guidance of the registration supervisor, including domestic and international registration documents.

　　4. Track registration progress, communicate and coordinate with drug regulatory authorities to ensure smooth processing of registration applications.

　　5. API registrars also need to track the progress of drug registration, implement on-site inspections related to drug registration applications if necessary, and assist with on-site assessments required for product registration submissions.

　　6. Responsible for promoting policies and regulations within the company and conducting compliance inspections.

　　7. Required to have certain laboratory skills and data analysis capabilities; participate in drafting relevant quality research protocols when necessary; responsible for regulatory compliance review of API quality research experimental protocols to ensure smooth progress of registration work.

　　8. Obey arrangements to participate in quality work related to drug registration.