Primary Function：
The position supports the subordinates and the unit in development, implementation, and achievement of the department goal, strategy and financial metrics.
Uses his/her project and submission management experiences to provides the overall supervision and guidance for the regulatory affairs to the project and/or the regulatory subordinates.
Supports the account manager to identify and develop sales opportunities and generates the regulatory strategy and/or relevant service scope and budget tailored to client’s need.


Key Responsibilities：
Personnel Management
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Provides supervision and guidance to the subordinates for the project execution and/or identifies the resources needed to ensure the success of the team and/or their project(s)


-Responsible for the quality and consistency of work across the department

-Evaluate the project and backlog to generate and execute the staffing strategy (recruitment, training, and development of talents and evaluate the performance in a fair fashion per role/position with less guidance from Line Manager)

-Build teams in different disciplines and services by training and mentoring from each subject matter expert through the relevant methodologies, techniques, frameworks, etc.

-Engage the team and minimize the turnover rate

-Provide the leadership for the unit and across the department with support from LM as applicable

-Ensure the subordinates carries the same standard/role model to their direct reports for the department to reach the final goals with support from LM as applicable


Department Affairs

-Accountable for Regulatory Intelligence Management with the inputs from the senior management and/or technical experts and share the impact analysis and execution plan to the impacted department(s), as needed, with the guidance from the LM.
-Independently responsible, accountable, training and mentoring on Standard Procedure Management and initiate the change management to improve the service delivery, as applicable, with the guidance from the LM.


Project Execution

-Independently accountable/responsible and/or providing training/mentoring for different regulatory services included but not limited to CTD authoring, CTD document preparation and publishing, country submission, gap analysis, consultation, Regulatory project coordination, management and strategy.

-Responsible for the regulatory project governance, client’s pipeline management and maintain/engage client’s relationship with minimum guidance/support from LM
Commercial Support

-Support Account Manager to identify/develop sales opportunities and to generate the service scope and corresponding budget for regulatory related services as well as deliver sales presentations and participates in id defense meetings when needed

-Contributes information to support the account planning process and integrated marketing programs

其他信息
语言要求：英语、普通话