Lief Labs is a premier formulation and product development innovator and manufacturer of dietary supplements. Our in-house product development and R&D team creates the best-tasting and cutting-edge supplement formulations. Lief also houses a state-of-the-art, full-service Current Good Manufacturing Practice (cGMP) manufacturing facility, which offers custom solutions for many supplement categories. Lief collaborates with entrepreneurial firms to help them build premier brands. Our turnkey solutions allow us to engage in seamless partnerships that help brands with scalability and sustainable growth. Lief Labs is in the Santa Clarita Valley (Valencia, CA.)

Summary

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 Lief’s Organic Certifier to ensure full compliance with the USDA National Organic Program (7 CFR Part 205).
• Collaborate with Lief’s 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

Supervisory Responsibilities

No Supervisory Responsibilities

Minimum Qualifications

Education/Knowledge

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.

Work Environment

The office is clean, orderly, properly lighted and ventilated. Noise levels are considered low to moderate. Field conditions vary.

Exposed to various raw materials, including allergens (i.e. milk, eggs, fish, shellfish, tree nut, peanuts, wheat, soy).

Physical Demands

While performing the duties of this job, the employee may regularly require talking, hear and grasp items. This position is active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, and climbing all day.

Regularly exposed to moving mechanical parts, strong fumes, loud noises, and occasionally extreme temperatures

The employee must frequently grasp, lift and/or move items 10 pounds and occasionally grasp, lift and/or move items 33lbs.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Additional Information
The Hourly Range for this position at Lief Labs is $25.00 - $30.00/ hour (USD). Starting pay for the successful applicant depends on a variety of job-related factors, including but not limited to market demands, experience, training, skills, and education. The benefits available for this position include medical, dental, vision, 401(k) plan, life insurance coverage, wellness benefits, education reimbursement program, and PTO.

Lief is an Equal Opportunity employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, or sex, including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Suppose you are a qualified individual with a disability or a disabled veteran. In that case, you have the right to request accommodation if you are unable or limited in your ability to use or access our career center due to your disability. To request an accommodation, contact the Lief Human Resources department.

Lief will consider employment-qualified applicants with criminal histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring.

Lief uses E-Verify to confirm work eligibility in the United States. E-Verify compares the information on your Form I-9, Employment Eligibility Verification, to official government records.