Regulatory Affairs Specialist at Nutrastar Inc
Farmingdale, NJ 07727, USA -
Full Time


Start Date

Immediate

Expiry Date

22 Oct, 25

Salary

70000.0

Posted On

23 Jul, 25

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Pharmaceuticals

Description

Position Description: Shifts: Mon-Thurs 8:00 AM - 5:00 PM , Fri 8:00 AM - 2:00 PM

POSITION SUMMARY:

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

EDUCATION/EXPERIENCE:

  • Knowledge of proper cleaning techniques, procedures, and equipment.
  • Previous experience in janitorial or custodial work preferred.
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, R&D, 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.
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