Associate Regulatory Operations Manager (NDA Filing))

中国, 上海, Shanghai
中国, 北京, Beijing

en de fr es ru tr it pt ja

Job summary

As a key member of filing teams, actively contribute to the development of project filing strategy, and then help and monitor teams to effectively and efficiently deliver objectives agreed with the relevant governance body and timeline. Partners with the team leader to anticipate, identify, manage and communicate project risks. Delivering high quality project management support and other high value services:

  • Applies project management expertise
  • Takes accountability for all project management aspects and works effectively and closely with the project leader/ core team members/ extended team members/ external stakeholders.
  • Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
  • Lead team to contribute the functional excellence development of project management (optional)

Support line manager to build and improve the capacity and capability regulatory operations team

Job required competency

Accountable for the development, maintenance, pro-active tracking & management of a high quality and integrated project plan, to which all sub-teams and functions are aligned

2.          Facilitate & lead team through the planning process. Build templates & tools and gathering examples to enable filing teams

3.          Coordinate and drive team meeting. Take meeting minutes. Ensure effective and efficient team operation

4.          Responsible to build timeline and modify process together with team’s input. Track actual timeline and filing progress.  Provide data points for metrics analysis

5.          Assist on resource planning & corporate processes  

6.          Perform critical path analysis. Accountable to closely and transparently manage the critical path of the project

7.          In partnership with the team leader ensures the team achieves and maintains a sustainable high level of performance

8.          Can take on leadership of the team as a delegate of the team leader

9.          Actively contributes to best practices and continuous improvement within the Project Management group and function level

10. Mentors and coaches other PMs and is committed to own and other professional development

11. Maintains working knowledge of filing related software

12  Project Management certification (i.e.: PMP) or equivalent experience would be preferred

13  Maintain knowledge of the drug development process relevant to the pharmaceutical/ biotech industry and experience supporting cross functional drug development project teams. Demonstrated ability to translate strategy into action

14. Be responsible of maintaining the Plan source and provide support to other operations activities

15. Complete all assigned mandatory training (global procedures, functional procedures, and business compliance) by the designated due date

16.       Leadership competency

-Works effectively with other people over whom he or she has no direct authority

-Be good at promoting an idea or vision

-Seeks common ground in an effort to resolve conflicts

-Influences with a sense of purpose, displays passion and conviction

Education/Qualifications

Bachelor Degree or demonstration of appropriate professional knowledge and aptitude.

Relevant working experience

* > 5 years’ experience in MNC Pharma company, at least 3 years in Regulatory

* independent working

* experience in handling regulatory projects, various kinds of regulatory submissions/approvals is a plus

Language and PC Skills:

Chinese (mother-tone level) and English (proficiency level)  

Computer skill: word, excel, power-point, smartsheet and project management software such as Microsoft project and milestone.                                   

                                   

Travel Frequency

25% - 50%