Regulatory Affairs Specialist
Listed on 2026-02-16
-
Quality Assurance - QA/QC
Job Title
:
Regulatory Affairs Specialist
Location: Wall, NJ
Compensation: $70,000
The Regulatory Affairs Specialist ensures compliance with applicable regulatory requirements and supports product certifications across the entire lifecycle of dietary supplements. This role manages everything from raw material reviews to final product labeling, ensuring all processes meet FDA, NSF, USDA, and customer standards.
Key Responsibilities- Compliance Management: Ensure products, labels, and documentation meet U.S. and global standards, including 21 CFR Part 111
, 117
, NSF 455-2, and general Food Safety regulations. - Label & Claim Review: Approve product labels, marketing claims, and packaging components (Supplement Facts, structure/function claims, etc.) for regulatory accuracy.
- Documentation: Prepare and maintain Product Ingredient Master Files, Finished Product Specifications, Certificates of Compliance (COCs), and Safety Data Sheets (SDS).
- Certifications: Act as the primary SME and point of contact for certification bodies (NSF, QAI, Non-GMO Project, etc.). Manage submissions and renewals for:
- USDA Organic & Non-GMO Project Verified
- Vegan, Gluten-Free, Kosher, and Halal
- Supply Chain Oversight: Ensure raw materials and finished products meet certification-specific requirements, including approved sourcing and formulation restrictions.
- Audit Support: Participate in customer, regulatory, and certification audits as the technical expert for documentation.
- Cross-Functional Collaboration: Partner with Procurement, R&D, QA, Sales, and Production to align regulatory objectives with business operations.
Minimum Qualifications
- Experience: Minimum of 3 years in a regulatory affairs or compliance role.
- Education: Bachelor’s Degree required.
- Technical Knowledge: Deep understanding of 21 CFR 111 (cGMP),
FSSC 22000
, and 7 CFR 205 (National Organic Program).
- Strong attention to detail and commitment to high‑quality standards.
- Excellent time management and the ability to prioritize tasks in a fast‑paced environment.
- Ability to work both independently and as a collaborative team member.
- Effective communication skills for responding to internal and external inquiries.
Physical Requirements
- Safety Adherence: Strict adherence to OSHA Manufacturing Safety guidelines, GMP guidelines, and biohazard safety standards.
- Physical Demands: Ability to stand for extended periods and lift/push/pull up to 25 lbs from floor to chest height.
- Environment: Must be comfortable working in a facility exposed to powders, chemicals, and common allergens (nuts, dairy, soy, wheat, etc.).
MOHR Talent is an equal‑opportunity employer and complies with all applicable federal, state, and local nondiscrimination laws. We provide equal employment opportunities regardless of race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, gender identity, genetic information, military/veteran status, or any other protected status. If you believe you have been discriminated against or have concerns about our compliance, please contact our Human Resources department at
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