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Regulatory Affairs Associate
2 months ago
Regulatory Affairs Associate
Client Park IL
5 MONTHS
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 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 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.
