Qualification and ability requirements for raw material registration personnel:
1. Bachelor's degree or above in Pharmacy or Pharmaceutical Analysis.
2. Obtain a certificate of English proficiency level 6 or above; Graduates with a major in Pharmaceutical Foreign Language are not subject to any restrictions on English proficiency exams.
3. Has high learning ability, can quickly familiarize oneself with various guiding principles such as CFDA/1CH/FDA/EMEA, and has good English listening, speaking, reading, and writing skills.
4. Strong sense of responsibility, strong communication skills, independent work ability, teamwork ability, and learning ability are required.
5. After a six-month probationary period, the ability to review and submit research documents for DMF document preparation under system training to ensure compliance with technical requirements of various registered countries.
Responsibilities of API registration officer:
1. Able to prepare registration documents for active pharmaceutical ingredients according to the registered countries (non mainstream countries and domestic); Ensure that all submitted materials comply with relevant regulations and technical guidelines, so that the registration application can be approved smoothly
2. Able to apply in a timely manner according to the drug registration procedures and comply with the registration procedures of the drug regulatory authorities. Standardize the handling of relevant procedures.
3. The raw material registration officer shall prepare relevant materials for drug registration applications under the guidance of the registration supervisor, including domestic and international registration materials.
4. Track registration progress, communicate and coordinate with drug regulatory authorities to ensure smooth registration applications.
5. The raw material registration officer also needs to track the progress of drug registration, implement on-site inspections that may involve applying for drug registration, and assist in on-site assessments required for product registration applications.
6. Responsible for promoting policies and regulations within the company and conducting compliance checks
7. Require them to possess certain laboratory skills and data analysis abilities, participate in the preparation of relevant quality research plans when necessary, be responsible for the regulatory compliance review of raw material quality research experimental plans, and ensure the smooth progress of registration work.
8. Obey arrangements to participate in quality work related to drug registration.