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Regulatory Affairs Associate

3 months ago

Lake Bluff, United States Gforce Life Sciences Full time

Regulatory Affairs Associate -- On-site in Abbott Park, IL

Must be able to work on a W2

Job Summary: We are seeking a dedicated Regulatory Affairs Associate to join our team. In this role, you will support the preparation and submission of regulatory documents to ensure compliance with all applicable regulations. The ideal candidate will have a keen attention to detail and strong communication skills to effectively interact with regulatory bodies and internal stakeholders.

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

  • Prior experience (2-3yrs) and Bachelors 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.

Term and Start

  • 8 month contract
  • On-site in Abbott Park, IL
  • Pay rate: $26-30/HR

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