Date Posted: 07/01/2024

Hiring Organization: Rose International

Position Number: 466741

Job Title: Regulatory Affairs Specialist

Job Location: North Chicago, IL, USA, 60064

Work Model: Onsite

Shift: 7.00 am to 4.00 pm

Employment Type: Temporary

Estimated Duration (In months): 6

Min Hourly Rate($): 35.00

Max Hourly Rate($): 35.00

Must Have Skills/Attributes: Documentation, Regulatory Affairs

Job Description

• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

Education:

• Prior experience (2-3yrs) and Bachelor’s degree in nutrition/science related field

Requirements include:

• 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

• System VEEVA experience is helpful

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.

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

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.

Benefits:

For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).