Primary Job Function:

Works in a strategic role and demonstrates organizational influence

1. Product registrations /Submissions

-Develops and directs regulatory plans for product and/or geographic groups assigned and ensures they are in-line with business needs

-Reviews regulatory data packages for major submissions prior to filing and during the approval process

2. Relationships & Cross Functional team work

-Maintains effective working relationships with Divisional RA

-Negotiates with and influences Manufacturing, QA, Commercial, Development management to support EPD regulatory needs

-Trains, develops and manages an effective team

3. Compliance across Life-Cycle

- Ensures that all new products are registered, and the existing marketed product registrations are maintained

globally in line with business needs and regulatory standards

-Identifies areas of regulatory or compliance risk, and establishes programs to reduce risk

-Supports team to assure products remain in compliance

4. Strategy

Ensures that agreed regulatory strategies are efficiently implemented, and that strategies are maintained inline

with changing regulatory needs and business needs

-Develops and implements internal and external strategies to proactively influence legislation/guidelines with

impact on Abbott business

-Sets policy and assures standard interpretation of regulations

-Provides regulatory leadership and expertise to licensing colleagues

-Conducts succession planning

-Provides strategy and direction to teams involved in agency activities

5.  Process Improvement

-Champion business and efficiency improvements

- Establishes vision and drives change management initiatives

6. Health Agency Interaction

- Attends at Agency meetings such as key policy meeting, major filing or strategy meetings

- Directs and/or provides input into interaction/communication with Agency reviewers and key Agency senior policy staff.

7. Licensing Reviews

-Actively supports in-licensing opportunities.

8. People Management

- Manage and empower the RA team by open communication, regular performance review, prompt and appropriate feedback and coaching, employee training needs analysis and practice

- Provide the necessary leadership to ensure appropriate direction, employees’ motivation and efficient accomplishment of key performance results

- Create and maintain a workplace culture which attracts, grows and retains highly qualified employees by proper succession planning and talent development policies and tools

- Demonstrate, promote and live the COMPANY Values in all interactions

Core Job Responsibilities:

Provide strategic input into the development of assigned projects, handling complex issues and providing leadership where appropriate to assigned team.

Responsible for managing strategic partnership with Manufacturing, QA, Commercial, Development and Divisional RA

Represent RA at China management meetings

Support strategic regulatory plans and present to management for agreement.

Ensure development and execution of China regulatory strategies for all projects consistent with commercial strategies.

Resolve complex issues with cross functional senior counterparts as required, ensuring compliance with regulatory and scientific standards, and identification of regulatory risk.

Monitor actual vs. planned activities and timelines.

Identify and recommend improvements to correct or accelerate project progression.

Manage regulatory resources within assigned area to ensure regulatory approvals.

Prepare and present written and oral reports and other presentations to internal and external audiences

Adjusts presentation style and content to suit the audience across.

Direct and manage the preparation and review of technical strategic regulatory documentation for agency submission.

Sets quality and accuracy standards for staff team and ensure application