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Regulatory Coordinator

Confidential
Chadds Ford, PA

Quick Apply

Job Details

Temporary | Contract
$21 - $25 an hour
7 days ago

Qualifications

Research
E-procurement
Reverse auction
Logistics coordinator experience
Request for proposal
Supply chain coordinator experience

Full Job Description

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

Quick Apply

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