Regulatory Affairs Associate - North Chicago, United States - Validation Associates

Validation Associates
Validation Associates
Verified Company
North Chicago, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Description:


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.

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

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:


Requirements include:


  • Prior experience (23yrs) 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
  • Selfmotivated.

Job Type:
Contract


Pay:
Up to $35.00 per hour


Schedule:

  • 8 hour shift

Education:


  • Bachelor's (required)

Work Location:
On the road
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