Job title- Regulatory Affairs Associate

Abbott Park, IL with zip 60064

Duration – 6 Months

Pay rate $33/hr

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

Requirements include:

§ Prior experience (2-3yrs) 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

§ Self-motivated.