What are the responsibilities and job description for the Regulatory Affairs Associate position at Intellectt Inc?
Role: Regulatory Affairs Associate
Location:Chicago, IL
Duration: 8 Months contract only
Shift Timings: 7 am to 4 pm
Major Responsibilities
Location:Chicago, IL
Duration: 8 Months contract only
Shift Timings: 7 am to 4 pm
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
- 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 centre & Product Developers.
- 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.
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