Regulatory Specialist
Actalent
Job Title: Regulatory SpecialistJob Description
We are seeking a dedicated Regulatory Specialist based in Chicago, IL. This role involves ensuring compliance with FDA regulations and standards in product labeling and commercialization projects.
Responsibilities
+ Create ingredient statements and nutrition fact panels.
+ Review and approve raw material and formula compliance through FDA regulations and standards within PLM.
+ Provide ingredient, formula, claim, labeling, and regulatory guidance to cross-functional teams on commercialization projects, including formula renovations, ingredient supply chain continuity, and formula line extensions.
+ Work cross-functionally to review label content to ensure regulatory standards.
+ Work within SAP PLM to review and approve ingredients, formulas, and graphics.
+ Research and stay abreast of upcoming regulatory changes, as well as identify and assess regulatory risks in commercialization projects.
+ Develop SOPs with related trainings.
+ Co-lead third-party certification audits.
Essential Skills
+ Experience with CFR21 and FDA regulations.
+ Proficiency in SAP and food regulatory standards.
+ Ability to write ingredient statements and nutrition fact panels.
+ Experience reviewing ingredients, formulas, and graphics.
+ 2+ years of experience in a food regulatory position following US FDA regulations.
Additional Skills & Qualifications
+ Familiarity with PLM or SAP systems is a plus.
+ Experience with Dragonfly, food label review software, PLM, artwork review.
+ Knowledge of DSHEA regulations.
Work Environment
This is a remote position with a preference for local candidates, ideally in the CST time zone. The work hours are Monday to Friday, 8 AM to 4 PM, with flexibility to adjust to 7 AM to 3 PM or 9 AM to 5 PM. The position is expected to extend to Q1 of 2027.
Pay and Benefits
The pay range for this position is $30.00 - $34.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Jun 21, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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