Em Regulatory Partner

7 months ago


Mumbai, India Abbott Laboratories Full time

**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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