What are the responsibilities and job description for the Regulatory Affairs Associate - Medical Devices position at Intellectt Inc?
Role: Regulatory Affairs Associate
Location: Abbott Park, IL - 60064
Duration: 8 Months contract only
Shift Timings: 7 am to 4 pm
Accountability / Scope
Location: Abbott Park, IL - 60064
Duration: 8 Months contract only
Shift Timings: 7 am to 4 pm
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 an approach to solutions.
- Individuals shall be good with excel and numbers, so that they can help analyze submission numbers & various metrics.
- 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 center & Product Developers.
- Prior experience (2-3yrs) and Bachelor’s degree in nutrition/science related field.
- Good understanding and working experience in different regulatory environments 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.
