Regulatory Affairs Associate

4 weeks ago


North Chicago, United States GForce Life Sciences Full time

Regulatory Affairs Associate On-site near North Chicago, IL (60064)

Term & Start

8-month contract with possibility to extend (5/6-EOY)

Pay rate: $25-30/hr ($50-60k annually)

On-site near North Chicago, IL (60064)

FT hours, M-F 8a-5p

Day-to-Day Duties

  • Support Regulatory submissions for Food, FSMP, Enteral Nutrition, IF & FUF, Drug for EURI/ MENAP/ global.
  • Assist in developing 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.
  • Support project plans, regulatory submission strategy, manage any risks.
  • Assist project teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
  • Support review of change controls to determine the level of change and consequent submission requirements.
  • Support pulling reports, metrics related to submissions and approvals.
  • Offer country-specific regulatory support.
  • Direct interaction with 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.

Qualifications

  • Prior experience (2-3yrs) and bachelors degree in nutrition/science related field.
  • Strong 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.


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