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  • Regulatory Specialist

    Actalent (Fresno, CA)



    Apply Now

    Description

    Core Responsibilities: Lead the management of technical requests for all health care products. Develop regulatory documentation related to ingredients, formulations, and labels and ensure compliance with corporate and FDA regulations. Complete technical document requests (statements to include specifications, nutritional composition, GMO, gluten, export certs, etc) to meet customer expectations in documentation turnaround time and accuracy. Manage the regulatory process for commercialization of health care products for assigned customers (Label setup, internal specification documentation set up, customer product database set up etc). Review and approve healthcare/nutrition product claims to ensure compliance with FDA, FTC, and other applicable regulations. Substantiate claims with scientific evidence and maintain supporting documentation and advise Marketing, Sales, and R&D on compliant claim language and guardrails Strategically manage large documentation projects and ability to support customer specific software programs. Review and create unit labels and case coding in compliance with all FDA regulations and customer specific requests. Review and Approve labels in compliance with all FDA regulations and provide guidance on product label and formula compliance in regions Lyons has a business interest. Manage the formula entry and formula change process Act as a lead for all regulatory export documentation (Certificates of Free Sale, Health and Quality Certs, Declarations) Monitor regulatory changes and assess potential risks to claims or communications. Responsible for reviewing respective required raw material documents for regulatory clarity. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents and recommend changes to company procedures in response to changes in regulations or standards. Serve as a company representative / technical liaison with corporate and professional organizations where we do business. Ability to act as a back up to the Regulatory Manager as needed. Performs other related and assigned duties by senior management.

     

    Skills

     

    Label Creation, Claims, ERP, International Compliance

     

    Top Skills Details

     

    Label Creation,Claims,ERP

     

    Additional Skills & Qualifications

     

    Required Qualifications: Minimum of B.S. Degree in Food or Nutritional Sciences, Biology, Chemistry or related field. Professional experience will be considered in lieu of a degree 5-10 years of relevant work experience within the food-manufacturing environment, Experience in Health Care regulatory claims, labeling, customer interface, and technical documentation. Must be computer literate and detail oriented. Preferred Qualifications: International compliance experience is a plus.

    Experience Level

    Expert Level

     

    Job Type & Location

     

    This is a Contract to Hire position based out of Fresno, CA.

    Pay and Benefits

    The pay range for this position is $32.00 - $42.00/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 onsite position in Fresno,CA.

     

    Application Deadline

     

    This position is anticipated to close on Jan 23, 2026.

    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 [email protected] (%[email protected]) for other accommodation options.

     


    Apply Now



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