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Job Responsibilities:

1. Timely track and interpret registration regulations, organize regulatory learning, and continue the review and approval process of the declared varieties, promptly solve or provide feedback on any issues that arise during the process;

2. Responsible for collecting information on company project initiation and writing research reports on project initiation information; And develop a project application plan;

3. Responsible for regularly organizing project meetings, following up on the research and development progress of ongoing projects, and identifying any potential issues during project implementation

Communicate, discuss and resolve issues and risks in a timely manner, and promote implementation;

4. Regularly organize and send project research weekly, monthly, and phased research reports to clients, and coordinate and communicate with clients on project related matters on behalf of the company;

5. Responsible for organizing and reviewing the completion of research work during the project phase, and evaluating the quality of project team work completion;

6. Responsible for organizing the compilation, writing, and review of project registration application materials, and preparing all registration related materials in accordance with CDE requirements;

7. Complete other tasks assigned by department leaders.

Job requirements:

1. At least 1 year of experience in drug research and development, major in pharmacy, chemistry, or related fields, with a bachelor's degree or above. Experience in R&D project management is preferred;

2. Familiar with drug registration regulations and technical guidelines, familiar with drug development processes;

3. Familiar with the drug registration and application process and various links, familiar with the writing of application materials, and have the ability to review application materials; Priority given to those who have experience in summarizing and organizing CTD registration application materials, writing materials, and submitting application documents;

4. Strong information retrieval and analysis research skills, good project operation skills, and experience and ideas in problem-solving; Familiar with R&D project management and GMP management knowledge is preferred;

5. Having a strong sense of responsibility, strong communication skills, independent work ability, and teamwork ability;

6. Proficient in operating various office software.

Job Responsibilities:

1. Able to independently complete experiments according to the plan formulated by the direct supervisor or manager, under the guidance of the supervisor, write experimental records as required, and be able to organize and summarize data and paper materials;

2. Able to comply with laboratory regulations and complete experimental tasks assigned by leaders according to project progress;

3. Complete some daily routine tasks (such as laboratory specifications, duty arrangements, etc.) in accordance with departmental regulations;

4. Fill in relevant experimental records in a timely and accurate manner, and be responsible for the inspection results to ensure the authenticity and reliability of experimental data during the drug development process.

Qualification:

1. Bachelor's degree or master's degree in analytical chemistry, pharmaceutical analysis, medicinal chemistry, pharmacy, pharmaceutical preparations and other related majors, with more than one year's working experience;

2. Having relevant experience in the testing industry or experience in drug research and development is preferred;

3. Strong learning spirit, high sense of responsibility, good sense of teamwork, positive work attitude, able to cooperate with certain business trips according to project needs;

4. Ability to use various conventional analytical instruments (HPLC, GC, etc.) and related working software (CDS2, Empower3, etc.) is preferred;

5. Clear work mindset, proficient in using office software (Word, PowerPoint, Excel, etc.) for work reporting is preferred

Job Responsibilities:

1. Participate in the research and development of synthesis projects and ensure their smooth progress, solving problems encountered during synthesis.

2. Participate in project synthesis information research and conduct technical risk assessment on the project.

3. Participate in the development of the overall research and development plan for the synthesis of the project, and be responsible for completing the synthesis research work according to the project plan; Responsible for writing the synthesis research plan, responsible for project process research, production transfer, pre pilot, pre validation, and validation of 3 batches of transfer production.

4. Responsible for writing the CTD application materials for the synthesis section, responsible for writing the original records of the synthesis section, and responsible for writing the synthesis section of the weekly and monthly reports.

5. Responsible for other related work arranged by department leaders.

Job requirements:

1. Bachelor's degree or above in drug synthesis and related fields is required; At least 3 years of relevant work experience in undergraduate studies, and at least 1 year of relevant work experience in graduate studies. Familiar with pharmaceutical regulations, possessing the ability to solve common problems related to synthetic processes in drug research and development.

2. Good experimental operation ability, able to complete the formulation of experimental plans, and responsible for process optimization and pilot production amplification;

3. Good literature retrieval skills, familiar with commonly used pharmaceutical websites and databases.

4. Have the ability to independently write synthetic research experimental plans and analyze experimental results.

5. Familiar with CTD data format, able to independently write synthetic research content.

5. Have good comprehension skills, communication skills, and thinking and judgment abilities.

6. Proficient in operating various office software (Word, Excel, PPT, etc.), proficient in operating various professional software (ChemDraw, MestReNova, etc.).

7. Possess teamwork spirit; Strong sense of work responsibility, passion, and a strong sense of time nodes.