Em Regulatory Partner
7 months ago
**Core Job Responsibilities**:
- Provide strategic input into the development of defined tasks for assigned products/projects seeking guidance where appropriate.
- Provide input into global strategic plans as appropriate.
- Monitor actual vs. planned activities and timelines and identify issues impacting project progression.
- Assist with the preparation and review of technical strategic regulatory documentation for agency submission.
- Responsible for ensuring accuracy and quality of documentation.
**Position **Accountability/Scope**:
**_ Effective Interface within Region and broader Abbott Organization_**
- Works primarily with Regional organization (commercial, supply, quality.etc), Affiliate RA staff and Divisional RA contacts.
**_ Project or Geographic or TA Accountability_**
- Assist with projects within one or more therapeutic areas.
- Assist with geographic intelligence, liaison and affiliate support as provided and directed by manager - this role will primarily interact with Russia, CIS and Turkey - thus Russian or Turkish language skills is an advantageous
- Project assignments and strategic direction are provided by manager.
- Routine supervision of project activities is required
**_ Scope of Accountability _**_(budget, resources, planning)_**
- Accountable for assigned project/task scope; completion with scheduled completion date
- No direct budgetary responsibility
- Adheres to departmental guidelines on expenses
- Identifies opportunities for cost savings
**_ Resolution, Prediction of regulatory issues_**
Resolves current issues, learns and adjusts based on prior results.
Maintain awareness of new draft legislation and guidelines.
**_ Impact on regulatory policy and regulations _**
Follows policy to ensure standard interpretation of regulations for defined project or task.
**Minimum Education**:
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