Regulatory Affairs Manager

About the Job

Regulatory Affairs Manager

Company: Huisong Inc.

Location: Santa Ana, California, Orange County

Schedule: Part-time, approximately 10 hours per week

Work Arrangement: On-site

About Huisong Inc.

Huisong Inc., located in Santa Ana, California, is the U.S. office of Huisong Pharmaceuticals. Founded in 1998, Huisong Pharmaceuticals specializes in the research, development, and manufacturing of premium-quality natural ingredients for leading companies in the pharmaceutical, nutraceutical, food and beverage, and personal care industries. Today, Huisong Pharmaceuticals operates globally and offers an extensive portfolio of natural products and ingredients. Guided by its core values of Nature, Health, and Science , Huisong continues to advance medicine and nutrition in support of health and well-being worldwide.

Official Company Website:

Position Overview

Huisong Inc. is seeking an experienced Regulatory Affairs Manager to support regulatory strategy and compliance for dietary supplements, botanical ingredients, herbal extracts, and Traditional Chinese Medicine products.

The Regulatory Affairs Manager will support the U.S. business while collaborating with Huisong's corporate office, global teams, suppliers, and business partners.

Key Responsibilities:

• Develop and implement regulatory strategies for new and existing products, including dietary supplements, herbal extracts, botanical ingredients, and Traditional Chinese Medicine products.
• Lead or support FDA submissions and regulatory pathways, including New Dietary Ingredient Notifications, GRAS determinations, and applicable OTC monograph requirements.
• Support international product registrations, including EU Novel Food applications and Health Canada Natural Health Product registrations.
• Advise senior management on new and emerging regulations, including FDA updates, California Proposition 65, FSMA, and international regulatory developments.
• Ensure compliance with applicable current Good Manufacturing Practices, including 21 CFR Parts 111 and 117, ISO 9001 standards, and USDA and EU organic certification requirements.
• Manage FDA, NSF, customer, and third-party regulatory audits and oversee corrective and preventive actions.
• Review product labels, marketing materials, and product claims for compliance with FDA and FTC requirements, including structure/function claims and Traditional Chinese Medicine disclosures.
• Collaborate with Research and Development, Sales, Quality, and Supply Chain teams to align regulatory requirements with business goals.
• Work with global suppliers to ensure raw material compliance, including ingredient identity, adulteration testing, heavy metal limits, pesticide limits, and supporting documentation.
• Navigate regulations and standards specific to botanicals and Traditional Chinese Medicine, including the USP Herbal Medicines Compendium, World Health Organization guidance, and China NMPA standards.
• Address regulatory matters involving botanical adulteration, safety data, ingredient identity, and traditional-use claims.

Education and Experience Requirements:

• Bachelor's degree or equivalent education in pharmacy, chemistry, food science, herbal medicine, regulatory affairs, or a related scientific field.
• At least five years of regulatory affairs experience within the nutraceutical, dietary supplement, botanical, herbal medicine, or Traditional Chinese Medicine industries.
• Strong working knowledge of:
  • FDA 21 CFR Parts 111 and 117
  • Dietary Supplement Health and Education Act
  • New Dietary Ingredient Notifications
  • GRAS requirements
  • Current Good Manufacturing Practices
  • ISO 9001
  • Foreign Supplier Verification Programs
  • U.S. and international dietary supplement regulations
• Preventive Controls Qualified Individual certification is required.
• HACCP certification or related food-safety training is preferred.
• Regulatory Affairs Certification is a plus.

Additional Qualifications:

• Experience managing FDA, customer, or third-party certification audits.
• Experience working with international suppliers and corporate teams.
• Strong analytical, communication, organizational, and documentation skills.
• Ability to interpret complex regulatory requirements and provide practical guidance to leadership and cross-functional teams.
• Ability to work independently and manage priorities within a part-time schedule.