The position is responsible for development and implementation of Global Regulatory Affairs and Product Compliance to provide regulatory oversight of compliance program for dietary supplements (21 CFR Part 111), nutritional supplements, foods (21 CFR Part 117, 21 CFR Part 110) and personal care & cosmetics (Federal Food, Drug, and Cosmetic Act and Fair Packaging and Labeling Act). The position interfaces closely with Legal, Product Development and Quality Departments to ensure Federal, State, Local and International regulations and compliance efforts in maintaining food safety and cosmetics, label compliance, regulatory inspections, recall, complaints, product registrations and certifications.
Develop and manage compliance program for Food, Dietary and Nutritional Supplements under FDA Title 21 CFR Part 110, 111 and 117, etc.), and Personal Care and Cosmetics (Federal Food, Drug, and Cosmetic Act and Fair Packaging and Labeling Act)
Maintain and disseminate current knowledge of FDA and international regulation, guidance, standards and industry best practice
Ensure the company preparedness for regulatory inspection and lead preparation and execution of regulatory response
Develop and implement Food Safety Modernization Act (FSMA) compliance program
Review and approve new and existing label, formula, raw material and finished product specifications to assure compliance with regulatory requirements
Prepare and process documentation required for product registrations and certifications in applicable international markets and provide technical registration dossiers that fulfill specific country regulations
Assess House Brands claims, labeling, formulas and ingredients (labels, website, ecommerce, etc.) to ensure compliance with domestic and international regulations.
Monitor and review product formula changes and label revisions to ensure compliance with regulatory requirements
Approve the release of reviewed labels as directed
Manage third-party accredited certifications for Kosher, Halal, non-GMO, Organic, Gluten-free, etc.
Work closely with Quality Assurance Auditor for the internal audit program and corrective action/preventive action (CAPA) implementation
Manage and investigate customer complaints, root cause analysis for non-conforming products, and corrective action and preventive action
Perform periodic mock recalls, and participate in FDA product recall
Identify quality and regulatory challenges based on risk and global basis to ensure applicable requirements are met for House Brand products that are being sold world-wide
Conduct supplier and product risk assessments and identify vulnerabilities
Define and monitor metrics to track compliance and process effectiveness
Develop, design, write standard operating procedures (SOPs) ensuring compliance with the company's policies and FDA regulations
Assist Senior Quality Assurance Manager in ensuring compliance with Standard Operating Procedures (SOPs), GMP, regulatory requirements and Job Aids related to daily tasks
Perform other duties as assigned
The duties and responsibilities described above may provide only a partial description of this position. This is not an exhaustive list of all aspects of the job. Other duties and responsibilities not outlined in this document may be added as necessary or desirable, with or without notice.
Knowledge, Skills and Abilities:
Knowledge of FDA/ Local and Global regulations
Strong analytical, data management knowledge
Ability to communicate written and verbally in a professional manner with people at all levels of the organization and external contacts
Able to work in a fast pace environment
Detail oriented, strong analytical skills, team-player
Experience with Microsoft Office Suite (Word, Excel, PowerPoint)
Experience with Google Business Suite (Gmail, Drive, Docs, Sheets, Forms) preferred
Generally, requires three (3) to five (5) years of relevant industry experience in R&D, manufacturing, quality Assurance and/or regulatory affairs. PCQI certified a plus.
Bachelor’s Degree in Food Science, Chemistry or related field preferred, or a combination of education and equivalent work experience.
iHerb is a leading global e-commerce retailer with an emphasis on providing an exceptional selection of nutritional and wellness products for the past 25 years. With over 30,000 products shipped to over 180 countries, we provide the best overall value for natural products through an innovative and efficient supply chain process.
Our teams have a strong sense of commitment and pride in their work, which has allowed us to grow, even during the recent pandemic. At iHerb, our purpose is to empower people to enhance their health, happiness, and well-being — that starts with valuing our team members by providing a positive work environment with competitive benefits. Our five shared values unite our team members across the globe and provide a stable foundation. These values speak to who we are, the culture we’re building, and how every single team member contributes to our larger company vision.
iHerb's Shared Values
Focus on the Customer · Empower Our People · Be Entrepreneurial & Pivot Quickly · Embrace Diversity & Inclusion · Strive for Simplicity
At iHerb, we are dedicated to offering programs designed to help our employees and their families stay healthy, live well and plan for the financial future. Built on a strong foundation, our programs provide options and upgrades with flexibility, protection, and security in mind. Below is a snapshot of the benefits we offer our team members. For a more comprehensive listing, visit www.iHerbBenefits.com.
- Medical Care: Starting in 2021, iHerb covers 100% of the associated cost for medical benefits
- Dental and Vision benefits
- Safe Harbor 401(k) + company match (100% of the first 6% of the employee’s contribution)
- Company-paid Term Life Insurance
- Short and Long Term Disability
- Flexible Spending Account (for qualifying expenses)
- Pet Insurance
- Voluntary Supplemental Benefits
- Education Reimbursement Programs
- Professional Development and Job Training
- Wellness Programs with opportunity to earn up to $300 per year
We strive for innovation, targeted at delivering a customer-centric experience while transforming the online shopping experience. We change direction and define ourselves in the idea that individually we are incredible but united our growth is infinite and paramount to our success. iHerb strives to be the global industry leader!
iHerb is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. iHerb provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment.