Title: Regulatory Affairs Associate
Location: Abbott Park, Illinois
Duration: 7 Month Assignment
Accountability / Scope:
- As the professional in the Regulatory Affairs function, the individual will assist teams in the registration.
- of products by preparing documentation needed for registration in EURI/MENAP global.
- Individual shall develop partnership with other regulatory functions, affiliates & other stakeholder to
- define plan & strategy for submissions and any deficiencies and develop approach to solutions.
- Individual shall be good with excel and numbers, so that they can help analyze submission numbers &
- various metrics.
Responsibilities:
- Support Regulatory submissions for Food, FSMP, Enteral Nutrition, IF & FUF, Drug for EURI/ MENAP/ global.
- Possess well developed skills in supporting development of product registration dossiers, submission, progress reports, deficiencies, amendments, etc ...
- Support teams to develop regulatory submissions strategy and update strategy based upon regulatory changes.
- Partnership with affiliates to support regulatory agency interactions to expedite approval of pending registration.
- Participates/ Awareness on project plans, regulatory submission strategy, any risks management.
- Advises project teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
- Partner with other regulatory functions for smooth project transition and launch.
- Support review of change controls to determine the level of change and consequent submission requirements.
- Support pulling reports, metrics related to submissions and approvals.
- Offers country specific regulatory support.
Stakeholders:
- Direct interaction with RA functions including Regulatory Operations, Submissions Execution,
- Regulatory Project Management, Strategic Area and other stakeholders such as Project managers, Manufacturing Plants, affiliates, R&D, Technical center & Product Developers.
Skills/Experience Requirements
- Prior experience (2-3yrs) and bachelor’s degree in nutrition/science related field.
- Good understanding and working experience in different regulatory environment in multiple countries.
- Experience in registration filing process of new nutrition products preferred.
- Knowledge and understanding of formulation & scientific aspects of nutritional products.
- Decision Making/ Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
- Influence stakeholders on technical solutions.
- Adaptable in cultural and political diversity.
- Capacity to learn and challenge status quo.
- Team player
- Self-motivated.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.