Associate Director of Regulatory Affairs

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.


Personnel Management
-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

Employee Benefits:
Employment Type: Full Time Employee
Office Location: Tokyo or Osaka
Working Style: Remote
Salary Range: Up to 16mil.
Welfare and Insurances: All Covered
Reporting Language: Japanese

Requirements:
-9+ years RA experiences and/or equivalent competencies in pharmaceutical industry/clinical research.
-Leadership skills that include the ability to gain trust with a variety of clients as well as within the department
-Familiarity with ICH/GCP and all different regulatory guidance.
-Excellent interpersonal, verbal and written communication, organization and planning skills with an attention to detail.
-Ability to role model behaviors and ethics in line with company Mission, Vision and Values.
-Ability to work effectively with internal and external team members.
-Previous managerial experience required and demonstrate ability to manage and motivate direct reports
-Strong and proven negotiation, problem resolving, and management skills.
-A flexible attitude with respect to a fast-paced and rapidly changing environment and ability to adapt the changes
-Demonstrated ability to communicate and write English clearly, concisely, and effectively.
-Provides a full range of regulatory consulting services Provides a full range of regulatory consulting services