International Regulatory Affairs / Quality Assurance Associate - Louisville, CO.

Position Overview

We are seeking a highly detailoriented International Regulatory Affairs / Quality Assurance Associate to support our global compliance operations. This role is responsible for preparing, managing, and maintaining regulatory documentation, international product registrations, certificates, technical files, and global label compliance. The position plays a key role in ensuring that our products meet all applicable regulations across multiple international markets.

Key Responsibilities

International Regulatory Affairs

• Prepare and coordinate regulatory submissions, product registrations, renewal packages, and Certificates of Free Sale for global markets.
• Review international product labels, claims, and marketing materials for compliance with regionspecific regulations (EU, UK, GCC, Canada, AsiaPacific, LATAM, Australia, etc.).
• Stay informed on global regulatory frameworks and emerging regulatory changes for dietary supplements, foods, cosmetics, and related categories.
• Conduct regulatory assessments for ingredients, formulations, and permissible claims based on foreign regulatory requirements.
• Develop and maintain technical files required for global registrations and audits.
• Track and manage timelines for submissions, approvals, and renewals across international markets.
  
  

Documentation & Certificate Management

• Prepare documentation packages including Manufacturer's Declarations, Free Sale Certificates, GMP/ISO certifications, ingredient documents, specifications, and testing reports.
• Provide technical and regulatory documents to global distributors and partners.
  
  

Import/Export Regulatory Compliance

• Evaluate compliance with international import/export requirements such as HS codes, EORI numbers, customs documentation, and countryspecific clearance requirements.
• Assist in resolving regulatoryrelated customs holds and shipment delays.
  
  

Quality Assurance Support

• Support change control, deviations, document control, and other QA processes related to international products.
• Participate in crossfunctional projects and provide regulatory guidance.
  
  

Required Qualifications

• Bachelor's degree in a related field.
• Minimum 3 years of experience in Quality Assurance or Regulatory Affairs.
• Experience in the nutraceutical or dietary supplement industry.
• Knowledge of FDA regulations for dietary supplements and foods (21 CFR 111, 21 CFR 117, DSHEA).
• Experience in cGMPregulated environments.
• Intermediate proficiency in Microsoft Office.
  
  

Preferred Qualifications

• 3 years of international Regulatory Affairs experience.
• Familiarity with foreign regulatory frameworks (EU, UK, NNHPD Canada, TGA Australia, GCC, LATAM, AsiaPacific).
• Experience preparing or supporting international product registrations.
• Experience reviewing global labeling requirements.
• Knowledge of CBD, botanical, peptide, and hormone regulatory environments.
• RAC certification or similar credential.
• Multilingual ability.
  
  

Core Competencies

• Exceptional attention to detail and accuracy.
• Strong ability to interpret and apply international regulations.
• Ability to manage multiple projects and shifting priorities.
• Effective written and verbal communication, including with international partners.
• Strong organizational skills and ability to work independently and collaboratively.
  
  

Work Environment

This position operates in both a professional office environment and a clean, regulated manufacturing environment. Standard office equipment is used regularly. Some standing may be required during audits.

Equal Employment Opportunity

We are an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.