Job title: EM REGULATORY PARTNER
Job Location: Mumbai, India
Job Type: 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.
- 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.
AWARENESS AND APPLICATION OF REGULATORY INTELLIGENCE
- 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: Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, or related subject