1.Independently manage the company's product regulatory affairs activities, ensuring compliance with all relevant laws and regulations.

2.Develop and maintain a regulatory strategy that aligns with the company's product plan, and oversee the entire registration process.

3.Prepare, review, and submit dossiers and other regulatory documents to regulatory authorities.

4.Ensure the accuracy, completeness, and timeliness of all regulatory submissions 

5.Coordinate with cross-functional teams, to develop and implement product standards and ensure regulatory compliance.

6.Monitor and track regulatory developments, analyze their impact on the company and provide strategic guidance to senior management.

1.Master's degree or above in a relevant scientific or technical field.

2.Rich experience in regulatory affairs with a focus on innovative drugs.

3.Strong knowledge of Chinese regulatory requirements and guidelines for drug development, registration, and post-approval activities.

4.Familiar with various links in registration applications and have good ability to write and review CTD documents;

5.Excellent communication, organization, and project management skills, with the ability to work effectively in a cross-functional team environment.

6.Proficient in English, with excellent reading, writing, and speaking skills.

7.Proactive and results-oriented, with a strong sense of accountability and a commitment to delivering high-quality work.

1.Provide comprehensive support for the company's antibody macromolecule new drug development, including immediate and long-term strategic planning, and provide technical management and scientific guidance on project selection and project management.

2.Antibody engineering modifications, including but not limited to antibody affinity maturation, humanization, bispecific antibodies and other antibody engineering related work.

3.Responsible for the management and execution of antibody drug project development and completion of R&D project development implementation and summary and other related tasks.

4.Effectively manage the team, individual career planning and promotion of the team.

1.Six years or more of PhD in biochemistry and molecular biology, cell biology, immunology, pharmacology and other related fields.

2.Familiarity with large molecule drug development processes and extensive experience in antibody engineering (humanization, affinity maturation, antibody sequence optimization); six or more years of industrial experience in therapeutic antibody development; or experience leading at least two therapeutic antibody projects from development to IND filing.

3.Leadership of early stage therapeutic antibody development projects, including project initiation and review, drafting of study protocols and implementation of specific study plans, with knowledge and skills in areas such as monoclonal antibody manufacturing and screening, phage display technologies, antibody library design and other biologics-related technologies preferred.

4.Good communication and writing skills and a high level of work responsibility.

5.CET-6, excellent oral and written communication skills in English and Chinese.

6.Proactive, strong sense of responsibility and ability to work as a team.

1.Ability to conduct cell-related experiments in strict accordance with aseptic operation.      

2.Proficient in hybridoma process, including fusion, subcloning, strain building, screening, etc.                                                                                     

3.Experience in large-scale cell culture.                                                    

4.Ability to cooperate with antibody drug screening including sample taking, ELISA and FACS.

1.A positive attitude, serious and responsible work, careful, teamwork spirit.

2.Proficiency in cell culture.

3.Biology-related majors, college degree or above.

1.Assist R&D personnel in analyzing existing technologies and drafting technical disclosure documents.

2.Conducting patent searches and analysis on product/technology solutions.

3.Coordinating with external agencies to manage patent applications, trademark registrations, and other related processes.

4.Other tasks assigned by the leadership (technical assistance, market or legal research, etc.).

1.Bachelor's degree or above in science or engineering, with relevant work experience as a patent agent.

2.Proficient in patent search skills, with excellent English proficiency to read and analyze patent.

3.Strong logical thinking skills and excellent verbal and written communication skills.

4.Familiar with patent law and application process, able to independently draft patent applications, respond to examination opinions, and other intermediate documents.

5.Experience in the biopharmaceutical field and qualification as a patent agent are preferred.

1.Responsible for the development and testing of biological analysis methods related to DMPK in vivo and in vitro.

2.Familiar with the theoretical basis and use of related instruments such as LC-MS/MS, and having the skills of biological sample analysis and in vitro ADME experiments (such as PPB, liver microsome stability, CYP inhibition/induction), to design in vivo pharmacokinetic experiments, analyze data, and conduct research in vivo pharmacokinetics.

3.Collecting and organizing experimental data, writing experimental plans, reports, and summaries.

4.Responsible for the daily management of instruments, writing and updating related SOPs, and assisting in the management of laboratory experimental materials, reagents, and consumables.

1.More than five years of work experience in related fields such as biology, drug metabolism and pharmacokinetics, drug analysis, analytical chemistry, etc., with a master's degree or above (or equivalent).

2.Proficient in basic experimental operations such as drug administration and blood collection in rats, mice, or dogs.

3.Familiar with common analytical instruments such as HPLC, LC-MS/MS, and able to develop biological analysis methods to quantitatively analyze small molecule compounds in biological matrix samples.

4.Having rich professional knowledge and research skills in pharmacokinetics, and being able to independently design and complete pharmacokinetic-related biological evaluation research.

5.Being responsible and team-oriented, hardworking and diligent, good at expression, communication, and collaboration; passionate about DMPK and biological analysis work.

6.Priority will be given to those who have experience in animal experiments or pharmacokinetic-related work.

1.Proficiently carrying out organic synthesis reactions, analyzing results, and independently completing simple research projects;

2.Able to solve problems encountered in experiments;

3.Under the guidance of the team leader, completing basic literature review and spectroscopic analysis;

4.Scientifically analyzing problems encountered in experiments, proposing reasonable improvement suggestions, or drawing reasonable conclusions;

5.Clearly and completely complete experimental records, and write truthful, detailed, and reliable experimental reports.

1.Bachelor's degree in chemistry or equivalent theoretical and experimental level, fresh graduates are also acceptable;

2.Proficient in organic synthesis, separation, and structure identification skills;

3.Proficient in literature search methods, with excellent English reading and writing abilities;

4.Strong sense of dedication and responsibility, working carefully and meticulously.

1.Leading the team to conduct small molecular synthesis experiments, and effectively solve problems encountered during the research and development process;

2.Management the laboratory on a daily basis to ensure efficient and orderly experimentation;

3.Completing relevant work scientifically and efficiently;

4.Responsible for team building, training of new personnel

1.Major in organic chemistry, medicinal chemistry or related fields, with 2-3 years of relevant experience for PhD holders, and 10 or more years experience for Bachelor's and Master's degree holders;

2.Possess innovative thinking, strong ability to design synthetic routes, spectroscopic analysis and literature search capabilities;

3.Having experience in leading a team to solve synthetic technical problems encountered in experiments;

4.Understanding of new drug research and development processes, and those with experience in new drug design and structure-activity relationship research are preferred;

5.Strong sense of responsibility and teamwork spirit, good organizational and coordination abilities.

1. Plan. Lead, and coordinate multiple cross-functional research and development projects from feasibility to delivery, creating project schedules to facilitate communication and decision-making management tools.

2. Organize and lead project meetings, including recording meeting minutes, tracking key decisions and action items, preparing meeting agendas, coordinating external and internal team activities and disseminating project information

3. Consult with project sponsors and review project proposals to determine goals, time frame, funding, allotment of resources and procedures for accomplishing projects.

4. Lead cross-functional teams to execute project tasks to include effective creation and management of timelines, project deliverables, milestones, required tasks, budgets, resources, risks and project objectives.

5. Establish, track and manage project schedule/critical path activities, status reporting, and resource plan development to ensure projects are completed on time, on-schedule and within budget

6. Coordinate commitment to project scope and timelines from the project leaders, teams, and relevant stakeholders.

7. Ensure team members understand project objectives, specifications, deliverables, timelines and tasks through ongoing clear, concise communication managing project dependencies within a project and dependencies between related projects.

8. Identify and facilitate solutions to problems, bottle necks, deviations, risks and changes that could lead to planning conflicts, project delays or cost changes

9. Prepare and present status reports on project activities, timelines and deviations to management and stakeholders, identifying and escalating issues when critical risks arise to identify course correction and ensure progress.

10. Follow established project management practices, including management of scope, requirements, issues, and risks.

11. Tracks and manages project spend against approved budgets.

12. Ensure project compliance with Quality Management System, and regulatory practices and requirements.

13. Other job functions as assigned.

· Bachelor or above degree in business administration, life science, information technology or related field

· 2+ years of broad-based project management experience to include tracking and reporting responsibilities, with demonstrated achievements

and progressive responsibilities ideally within a life science environment and supporting clinical studies

· Demonstrated proficiency in managing multiple projects, and changing priorities to meet timelines and budgets

· Demonstrated proficiency to balance cost, quality and schedule constraints while escalating issues as needed

· Demonstrated ability to prioritize and balance multiple competing priorities within and across multiple projects at the same time.

· Demonstrated and effective communications/presentations, influence, outcomes, facilitation, and teamwork skills

· Success working in a cross-functional environment with competing priorities while driving for successful outcomes

· Demonstrated proficiency with MS Project, Excel and PowerPoint.

· Occasional overtime work

· Able to work at a computer for extended periods of time

· PMI or similar certification a plus