Regulatory Affairs Specialist at NutraStar Inc – Farmingdale, New Jersey

Location: Farmingdale, NJ  
Employment Type: Full-Time/On Site 
Pay Rate:  $65,000.00 - $70,000.00 Hourly
Hour Per Week: 40 hours per week
NutraStar is a fast-growing contract manufacturer specializing in the formulation and production of high-quality nutraceuticals. With more than 300 employees and a reputation built on customer service, precision, quality, and innovation, we serve some of the most respected brands in the health and wellness industry. Our continued investment in people, technology, and infrastructure drives our rapid growth and positions us as a leader in our field

About the role

The Regulatory Affairs Specialist ensures compliance with applicable regulatory requirements and supports product certifications across the lifecycle of dietary supplements, from new raw material review to final product labeling. This role manages documentation, regulation updates, certifications, and internal compliance processes to meet FDA, NSF, USDA, and customer requirements.

Key Responsibilities:

• Ensure products, labels, and documentation meet applicable U.S. and global regulatory standards (21 CFR Part 111, 117, NSF 455-2, Food Safety, etc.).
• Review and approve product labels, marketing claims, and packaging components for regulatory and certification compliance (e.g., FDA labeling, supplement facts, structure/function claims).
• Prepare and maintain regulatory documentation including product ingredient master files, finished product specs, COCs, and Safety Data Sheets (SDS).
• Manage and coordinate product certification processes for:
• o USDA Organic, Non-GMO Project Verified, Vegan, Gluten-Free, Kosher, Halal, and any other product certifications
• Act as the primary point of contact with certification bodies (e.g., NSF, QAI, Non-GMO Project etc.) and ensure timely submission and renewal of certifications.
• Ensure raw materials and finished products meet certification-specific requirements, including approved sources, documentation, formulation restrictions, and labeling standards.
• Track and communicate changes to regulatory or certification requirements that impact formulations, processes, or labels.
• Participate in audits (customer, regulatory, certification) and provide documentation as the Regulatory or Certification SME.
• Work closely with Procurement, Research and Development, QA, Sales, and Production to ensure alignment with regulatory and certification objectives.
• Respond to internal and external inquiries related to product regulatory status or certification eligibility.

Qualifications

• Minimum of 3 years’ experience 
• Bachelor's Degree
• Act with integrity and ask for assistance and clarification when questions/issues arise.
• Demonstrate mutual respect for all employees.
• Ability to thrive in a “Team Oriented Environment.”
• Ability to work independently if required.
• Knowledge of proper cleaning techniques, procedures, and equipment.
• Previous experience in janitorial or custodial work preferred.
• Knowledge of proper cleaning techniques, procedures, and equipment.
• Strong attention to detail and commitment to maintaining high cleanliness standards.
• Ability to work independently with minimal supervision.
• Excellent time management skills and ability to prioritize tasks effectively.
• Good communication skills and ability to work collaboratively as part of a team.
• Follow OSHA Manufacturing Safety Awareness and precautions.
• Comprehends and adheres to all pertinent Health and Safety Regulations, Policies and Procedures.
• Required to use all approved and issued Personal Protective Equipment as directed by policy and procedure.
• Report any safety issue (ie. injury, near miss, or hazards) or workplace accident to supervisor immediately.
• Ensure all GMP guidelines are adhered to, wear PPE, follow biohazard safety standards.
Additional Requirements

•  Lifting, pushing, and pulling products.
• Ability to handle 20-25 lbs. on a frequent basis from floor to chest high.
• Standing for extended periods of time.
• Work environment may be exposed to powders, chemicals, and allergens (peanuts, tree nuts, milk, dairy, eggs, wheat, gluten, soy, fish and shellfish.)
• The following Regulations must be adhered to:
• 21 CFR 111 cGMP in Manufacturing, Packaging, or Holding Operations for Dietary Supplements
• FSSC 22000 Food Safety Management System
• 7 CFR 205 National Organic Program (NOP)
• Knowledge, Skills and Abilities

Why Join NutraStar?

As a growing leader in the nutraceutical industry, NutraStar offers the opportunity to contribute to high-impact quality initiatives while working in a collaborative and safety-focused environment. You’ll play a vital role in ensuring product quality for customers worldwide