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Regulatory Affairs Associate
2 months ago
Job Title: Regulatory Affairs Associate
Type: Contract - 8 Months
Pay: $32.00/hr
Day -7 AM - 4PM
Location: 100 Abbott Park Road, Abbott Park, IL
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
Major 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
§ System VEEVA experience is helpful
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
Requirements include:
§ 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.
