岗位职责：

1. Responsible for China regulatory strategy development most independently. Align with China RA Head and CNWG. Provide China strategy to GRL and align with global strategy. Attend GPT and provide China inputs if needed. Manage overall China regulatory plan for product(s) (in partnership with RPM).

2. Accountable for the submissions most independently. Responsible for the submission strategy and the selection or review the core dossier for submission and provide inputs to GRL. Set up and lead the submission team. Review the submission content plan and review the timelines created by RPM. Lead China labelling strategy and execution. Report and update the  RA strategies/submission progress/key issues/strategies adjustment to related meeting bodies. Lead to response HA queries during review. Track/execute post-approval requirements or commitments.

3. Accountable and responsible for HA interactions for the given product(s) most independently. Develop and execute HA communication strategy.

4. Accountable for the post approval maintenance for the assigned product(s) most independently to ensure the product supply continuously.

5. Keep awareness of market intelligence and lead the assessment of competitors, proactively working on policy interpretation and policy advocacy.

资历要求：

1.    Master Degree or above, major in Medicine, Pharmaceutical Science, or other related subjects. prefer candidates trained with drug innovation related courses;

2.    10 years or above drug registration related experience (IND/NDA/PMRA);5 years above experience for oncology products;5 years above work experience in MNC

3.    Fully understand the current regulatory practices and regulation in China.

4.    Requires broader knowledge of R&D related disciplines.

5.    Provides technical guidance and direction from RA perspective.

6.    Understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making.

7.    Has knowledge of best practices.

8.    Is aware of the competition and the factors that differentiate them in the market.

9.    Requires a comprehensive understanding of how RA collectively integrates within the R&D in MNC.

10.   Explains complex information and works to build consensus in challenging situation.

11.   Collaborates effectively with members in R&D and other functions.

12.   Works effectively with people in other Areas and external stakeholders based on in-depth understanding of how RA integrates within a R&D.

13.   Evaluates situations using a diverse range of internal and external sources to solve complex issues which are typically unprecedented and go beyond application of knowledge and prior experience.

14.   Autonomous responsibility for planning and execution of a study/project.

15.   Work in ambiguous situations.

16.   Influences decisions through advice, counsel or facilitating services to others in area of specialization.

17.   Uses novel approaches, new ideas and knowledge to solve complex problems that requires evaluating situations using multiple sources of information.

18.   Utilize the knowledge of new information and changes in the environment to the problem solving.

19.   Excellent verbal and written communication skills and fluent in both oral and written English.

20.   Familiar with the use of Microsoft office;