Associate Director Regulatory Affairs

Key Responsibilities：

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

Preferred Experiences and Skills

• 9+ years RA experiences and/or equivalent competencies in pharmaceutical industry/clinical research.
• Leadership skills that include the ability to gain trust and confidence 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 conflict 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

Key Responsibilities：

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

Preferred Experiences and Skills

• 9+ years RA experiences and/or equivalent competencies in pharmaceutical industry/clinical research.
• Leadership skills that include the ability to gain trust and confidence 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 conflict 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