1. Product registrations /Submissions Provide strategic regulatory advice for assigned Development Programs and On-market products to I&D and in country / regional stakeholders Develop and manage global regulatory strategies ensuring appropriate input is received from functional subteam members Identifies/obtains data needed, and ensures that they are effectively presented for the registration of products Assesses scientific data provided by specialist units for registration purposes against regulatory requirements Manages the preparation of registration packages (including complex) and answers to deficiency letters -Ensures records of filings and approvals are maintained -Approves the complete regulatory data packages prior to filing and during the approval process -Prepares agency meeting packages, and develops strategies for agency meetings

2. Relationships & Cross Functional team work - Represents Regulatory Affairs at relevant meetings and presents agreed RA position and negotiates with and influences regional management (Manufacturing, Quality, Development, Commercial etc.) to ensure programs meet regulatory requirements - Monitor actual vs. planned activities and timelines. - Identify issues impacting project progression.

3. Compliance across Life-Cycle - Assesses and approves manufacturing change requests (if relevant to role) and updates filings accordingly -Assures investigational product submissions are updated appropriately throughout the development phase (where appropriate) -Maintains awareness of regulatory legislation and assesses its regional impact on business and Abbott EPD RA -Works to assure products remain in compliance

4. Strategy -Advises Business Partners ( e.g. Commercial, Development, QA, Manufacturing, New Business Development) on regulatory requirements. -Defines regulatory strategies for the registration of regional / global products -Provide regulatory expertise to licensing departments

5. Process Improvement -Identify and implement process improvements -Identify opportunities for business and efficiency improvements

6. Health Agency Interaction Attend Health Agency meetings as appropriate

7. Licensing Reviews Able to fully/independently represent RA on product in-licensing activities.

Core Job Responsibilities: -

Provide strategic input into the development of assigned projects handling complex issues, seeking guidance where appropriate. -Ensure input from cross functional team members and issues regional regulatory plans as appropriate. -Attendance at project teams as appropriate.

Prepare regulatory filings for submission. -Manage strategy for response to regulatory agency queries, ensuring scientific dossier content and consistency of scientific content and Company position. -Monitor actual vs. planned activities and timelines.

Identify issues impacting project progression and work with manager to recommend improvements to correct or accelerate project progression -Prepare and present written and oral reports and other presentations to team members and other internal audiences. Adjusts presentation style and content to suit the audience.

Manage the preparation and review of technical strategic regulatory documentation for agency submission. -Responsible for ensuring accuracy and quality of documentation. Support strategic regulatory plans and present to management for agreement - Maintains awareness of regulatory legislation and assesses its regional impact on busines