1.Work closely with technical team members, clients and BD/BO to ensure the proposals generated for API, Drug Product and Analytical development projects meet regulatory requirement for CMC development in new drug application (such as IND/IMPD) with both domestic and international regulatory agents.

2.Create and maintain detailed CMC project plans to ensure clarity of deliverables and timing.

3.Answer the CMC related questions from client and internal teams.

4.Coordinate meeting logistics including scheduling the meetings, sending out the agendas, writing and distributing minutes, tracking goals and action items, collecting meeting materials from line functions and distributing them to the team before the meeting.

5.Assist the preparation of the responses to questions from CFDA /FDA and client regards to the work conducted in STA.

6.Train the functional teams on the regulatory knowledge and requirement for CMC filing.

任职要求：

1. Education: BS, MS or PhD

2. Major: Pharmaceutical Sciences, Chemistry or related majors

3. Language: Proficient in English both written and spoken

4. Work Experience: BS over 10 years’ experience, MS over 7 years’ experience and 5 years’ experience in project management is must.

5. Skilled in CMC development and projects management experience

6. Best knowledge of policy and regulations with new drug declaration of FDA\CFDA and European Union, especially for CMC R&D (API, Formulation and quality), best knowledge of CMC responsibilities on CTD declaration documents.

7. Skilled on MS Project, Excel, PowerPoint, Word.

8. Excellent on expression and communication, team work spirit and good planner.

9. Focus on detail and be result driven, be a good leader.

上班地址：外高桥保税区德林路90号