at Industrial Staffing Services Inc dba Equiliem in Abbott Park, Illinois, United States
Job 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.
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
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.
We are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion, color sex, national origin, citizenship status, age, sexual orientation, gender identity, marital status, uniform service member status, genetic information, disability, or any other protected status, in accordance with all applicable federal, state, and local laws. This practice extends to all aspects of our employment practices, including but not limited to, recruiting, hiring, firing, promoting, transferring, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.
