Regulatory Affairs Associate - Chicago, United States - GForce Life Sciences

Description

Regulatory Affairs Associate On-site near North Chicago, IL 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 FT hours, M-F 8a-5pDay-to

• Day DutiesSupport 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.

QualificationsPrior 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.#J-18808-Ljbffr