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Description

The Quality Regulatory Affairs Specialist will be a key contributor to ensuring full compliance with regulatory standards while upholding the highest levels of product quality. You will collaborate closely with cross-functional teams to ensure adherence to current Good Manufacturing Practices (cGMP) and all applicable regulatory requirements. The ideal candidate is well-versed in 21 CFR Part 111, USDA, FTC, and other regulatory standards as needed. Success in this position requires strong attention to detail, excellent communication skills, and a solid understanding of regulatory affairs within the nutraceutical and dietary supplement industry.

Responsibilities

+ Review and approve raw material, packaging material, and finished product specifications, supplement facts panels, and labeling to ensure compliance with applicable regulations (e.g., 21 CFR Part 111, 21 CFR Part 101, FTC, USDA).

+ Provide regulatory guidance and support to cross-functional teams throughout the product lifecycle, from development to commercialization.

+ Collaborate with R&D and Quality teams to assess formulations and claims for regulatory compliance.

+ Collaborate with internal teams to facilitate certifications from regulatory bodies for new products, variations, and renewals.

+ Maintain and update regulatory documentation, including formulation sheets, product registrations, and master files.

+ Review/Approval of Master Manufacturing Record/Master Batch Record

+ Shelf-life / Stability Data Oversight

+ Review and approve substantiation for expiration dating or best by dating on dietary supplement labels in compliance with 21 CFR 111.75(c).

Claims Substantiation

+ Evaluate structure/function and other marketing claims for substantiation and compliance with DSHEA, FTC, and FDA guidance.

+ Risk Register / Label Approval Workflow

+ Maintain risk register for client-provided labels and approve/reject based on compliance criteria for internal company use only.

Regulatory Requests

+ Support clients with international product submissions and evaluate compliance with EU, Canada, etc.…

+ Prepare formal client requests, including claim substantiation statements (e.g., confirmation that a product meets gluten-free standards), safety data sheets for finished products, letters of guarantee, manufacturing statements, and related documentation.

+ Applying for import permits, Certificate of Free Sale Certificates, coordinate Apostille and Notary as needed for client exporting needs.

+ Respond to client inquiries regarding formulas, including questions on claim substantiation, GRAS status, NDI compliance, and related regulatory matters.

+ Review supplier-provided raw material and packaging material documentation, including but not limited to Certificates of Analysis (COAs), specifications, GRAS/NDI/ODI status, Safety Data Sheets (SDSs), process flow charts, nutritional information, composition statements, certifications/claims, and all other relevant regulatory and quality documentation.

+ Collaborate cross-functionally with Procurement and R&D to qualify suppliers by reviewing and validating onboarding documentation.

+ Collaborate with Organic Certifier to ensure full compliance with the USDA National Organic Program (7 CFR Part 205).

+ Collaborate with Halal and Kosher Certifiers to ensure full compliance with their standards.

+ Support customers in obtaining or maintaining certifications such as NSF, USP, Non-GMO Project Verified, USDA Organic, Kosher, Halal, Gluten-Free, Informed Sport, or Prop 65 compliance.

+ Monitor changes in regulations and guidance documents issued by regulatory authorities and communicate updates to relevant stakeholders.

+ Participate in continuous improvement initiatives to enhance regulatory processes and ensure alignment with industry best practices.

+ Provide training and support to employees on document control procedures, system usage, cGMP and employee hygiene on an annual basis, and all other relevant trainings needed for personnel to perform essential functions.

+ Educate internal teams (QA, R&D, marketing) on current regulatory requirements.

+ Act as the point of contact with certification bodies and auditors during application, renewal, or surveillance processes.

+ Manage and maintain facility licenses and certifications, ensuring compliance with local, state, and federal regulatory requirements.

+ Additional Duties as assigned

Skills

21 cfr, supplement, food ingredient, GRAS, Regulatory, Regulatory submission, Regulatory affairs, dietary, regulatory affairs certification, Fda, Labelling, Regulatory compliance

Additional Skills & Qualifications

Education: Bachelor's degree in a relevant scientific discipline (e.g., chemistry, biology, pharmacy) required; advanced degree preferred.

Experience:

Minimum of 3 years of experience in regulatory affairs within the dietary supplement, pharmaceutical, food and beverage or related industry.

Thorough understanding of FDA regulations (21 CFR) and other global regulatory requirements governing dietary supplements or pharmaceutical products.

Strong attention to detail and ability to prioritize tasks effectively in a fast-paced environment.

Excellent written and verbal communication skills, with the ability to interact confidently with internal teams and regulatory agencies.

Proven experience with regulatory submissions, regulatory agency interactions, and compliance activities.

Regulatory affairs certification (e.g., RAC) or equivalent credentials desirable but not mandatory.

A strong candidate can effectively communicate with technical and business stakeholders, as well as clients, to drive process improvements and maintain strong client relationships.l

Job Type & Location

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

Pay and Benefits

The pay range for this position is $25.00 - $30.00/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 Valencia,CA.

Application Deadline

This position is anticipated to close on Nov 26, 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 [email protected] (%[email protected]) for other accommodation options.