at Spectraforce Technologies Inc. in WaukeganNorth Chicago, Illinois, United States
Job Description
Job Title: Regulatory Affairs Associate
Location: North Chicago, IL 60064
Duration: 09 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 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
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.
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
