**_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 Agen_** **_cy 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 Additional Job Description **Position** **Accountability/Scope:** **_Effective Interface within RA (Divisional, Affiliate) and broader Abbott Organization_** Works with internal and external levels of the organization, usually at higher levels of the organization **_Project or Geographic or TA Accountability_** Manage Projects (Development, In-Licensing, Life Cycle) within China **_Scope of Accountability_** **_(budget, resources, planning)_** Oversees activities and prioritizes to assure costs are maintained within budget Accountable for input into strategic budgets, LBE and update planning with completion within scheduled completion date and within budget constraints. Provides input to secure and justify funding. Allocates resource across team to ensure effective use of available resources. **_Resolution, Prediction of regulatory issues_** Anticipate long-term future problems, resolve current issues. Learns and adjusts based on prior results and prior project leadership experience. **_Awareness and application of Regulatory Intelligence_** Develop and implement internal and external strategies to proactively: Take lead to respond to legislation/guidance with impact on Abbott business address changes in the regulatory environment impacting key projects Ability to take lead to help direct project teams to resolve regulatory issues. **_Impact on regulatory policy and regulations_** Assures review and application of policy within assigned area. Assesses regulatory issues for potential implications to projects outside of relevant area, and ensures communication and resolution including liaison with other functional areas as required. Ensures standard communication across all projects and external customers and stakeholders Leads teams to respond to health agency draft policy or scientific guidelines. **Minimum Education:** Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject. A relevant Master's Degree is preferred **Minimum Experience/Training Required:** 10 years in Regulatory, R&D or related area, minimum of 5-year experience preferred in pharmaceutical regulatory affairs, ideally includes at least 3-5 years team management experience Ability to operate across global cultures. Fluent English both oral and written. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com