Jr. Regulatory Affairs Associate
Jr. Regulatory Affairs Associate
Intellectt Inc
Abbott, TX
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Hi All,
One of my clients is looking Role: Regulatory Affairs Associate, if you’re interested or your skills matches, please share with me your updated resume to [email protected]
Job Title: Regulatory Affairs Associate
Location: Abbott Park, IL
Duration: 05 months
Shift Timings: 8:30 AM to 5:30 PM
Accountability / Scope
One of my clients is looking Role: Regulatory Affairs Associate, if you’re interested or your skills matches, please share with me your updated resume to [email protected]
Job Title: Regulatory Affairs Associate
Location: Abbott Park, IL
Duration: 05 months
Shift Timings: 8:30 AM to 5:30 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.
- Individuals shall develop partnership with other regulatory functions, affiliates & other stakeholder to define plan & strategy for submissions and any deficiencies and develop 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
- 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 the 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.
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Seniority level
Associate -
Employment type
Full-time -
Job function
Legal -
Industries
Staffing and Recruiting
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