Position Summary
Position Summary
The Regulatory Coordinator provides administrative and technical support to the Regulatory Department to ensure compliance with applicable federal and state regulations, customer requirements, and third-party certification standards for dietary supplement manufacturing.
This position plays a key role in supporting supplier qualification, raw material regulatory review, customer documentation requests, audit preparation, and document control activities. The Regulatory Coordinator works closely with Purchasing, Supply Chain, Quality Assurance, Manufacturing, Research & Development, and external suppliers to ensure regulatory compliance, maintain audit readiness, and support the successful introduction of new raw materials and products.
The ideal candidate is highly organized, detail-oriented, and possesses experience working within a regulated food, dietary supplement, pharmaceutical, or manufacturing environment.
Essential Duties and Responsibilities
Supplier Qualification & Compliance
- Assist with supplier onboarding and qualification activities.
- Prepare, organize, and maintain supplier qualification files.
- Maintain the Approved Supplier List (ASL).
- Request, review, and organize supplier documentation, including:
- Certificates of Analysis (COAs)
- Product Specifications
- Technical Data Sheets (TDS)
- Safety Data Sheets (SDS)
- Allergen Statements
- GMO Statements
- BSE/TSE Statements
- Country of Origin Statements
- Manufacturing Flow Diagrams
- Food Safety Certifications
- Third-Party Audit Reports
- Regulatory Compliance Questionnaires
- Monitor expiration dates of supplier documentation and certifications.
- Follow up with suppliers regarding outstanding qualification documentation.
- Assist in maintaining supplier compliance records.
Raw Material Regulatory Review
Assist the Regulatory Manager with the review and qualification of raw materials and packaging components by:
- Reviewing technical documentation and regulatory declarations.
- Evaluating ingredient regulatory status.
- Reviewing ingredient specifications and certificates.
- Assisting with ingredient qualification assessments.
- Maintaining ingredient qualification files.
- Supporting new raw material approval activities.
- Assisting with customer regulatory documentation requests.
Supplier & Ingredient Risk Assessment
Assist in preparing and maintaining:
- Supplier Risk Assessments
- Raw Material Risk Assessments
- Packaging Component Risk Assessments
- Ingredient Qualification Files
- Supplier Qualification Files
- Regulatory Review Summaries
Customer Documentation & Regulatory Support
Prepare and coordinate customer documentation packages, including:
- Allergen Statements
- GMO Statements
- BSE/TSE Statements
- Country of Origin Statements
- Organic Documentation
- Gluten-Free Documentation
- Kosher Documentation
- Halal Documentation
- Regulatory Questionnaires
- Product Certifications
- Manufacturing Statements
- Regulatory Compliance Letters
Support customer requests related to ingredient compliance, supplier qualifications, certifications, and product documentation.
Audit & Certification Support
Assist in preparing documentation and maintaining audit readiness for:
- NSF cGMP 455-2 Dietary Supplement Certification
- Gluten-Free Certification Organization (GFCO)
- Kosher Certification
- Pennsylvania Department of Agriculture
- U.S. Food and Drug Administration (FDA)
- Customer Audits
- Internal Audits
- SEDEX/SMETA Ethical Trade Audits (as applicable)
Responsibilities include:
- Preparing audit documentation.
- Organizing supplier qualification records.
- Maintaining audit binders and electronic files.
- Assisting with corrective action documentation.
- Tracking audit observations through closure.
- Supporting continuous audit readiness initiatives.
Regulatory Compliance
Assist the Regulatory Manager in supporting compliance with:
- 21 CFR Part 111 – Current Good Manufacturing Practice (cGMP) for Dietary Supplements
- Applicable FDA dietary supplement labeling regulations
- Supplier qualification programs
- Customer quality requirements
- Internal Quality Management System (QMS) procedures
- Food Safety Modernization Act (FSMA), where applicable
Document Control
- Maintain controlled regulatory documentation.
- Maintain electronic and hard-copy qualification files.
- Ensure current revisions of regulatory documents are maintained.
- Archive obsolete documentation in accordance with company procedures.
- Maintain regulatory tracking spreadsheets and databases.
- Assist with document revisions and approvals.
Cross-Functional Collaboration
Collaborate with:
- Purchasing
- Supply Chain
- Manufacturing
- Warehouse
- Research & Development
- Quality Assurance
- Sales
- Customer Service
- External Suppliers
- Customers
to facilitate timely completion of regulatory activities and customer requests.
Continuous Improvement
- Support continuous improvement initiatives related to supplier qualification, document management, and regulatory compliance.
- Recommend improvements to documentation systems and qualification processes.
- Assist in implementing new regulatory procedures, tracking systems, and departmental efficiencies.
Other Duties
- Assist the Regulatory Manager with special projects.
- Conduct regulatory research as assigned.
- Support departmental initiatives related to quality systems, certifications, and supplier management.
Perform other duties as assigned.
Qualifications
Education
Associate's or Bachelor's degree preferred in:
- Food Science
- Biology
- Chemistry
- Regulatory Affairs
- Quality Assurance
- Life Sciences
- Business Administration
Equivalent industry experience will be considered.
Experience:
Preferred:
- 2–5 years of experience in a regulated food, dietary supplement, pharmaceutical, or manufacturing environment.
- Experience supporting Quality Assurance or Regulatory departments.
- Experience maintaining controlled documentation.
- Experience with supplier qualification programs.
- Experience preparing documentation for third-party audits.
- Experience communicating professionally with suppliers and customers.
Pay: $21.00 - $25.00 per hour
Work Location: In person
