Regular Affairs Manager (Part-Time)

Huisong Pharmaceuticals; Santa Ana (CA); Vor Ort; USD 83.000 - 117.000; Teilzeit

Zusammenfassung

Huisong Inc. in Santa Ana, CA, is seeking an experienced Regulatory Affairs Manager to ensure regulatory compliance for botanical ingredients, natural products, and dietary supplements.

This hands-on, part-time role requires on-site presence in Santa Ana and a strong background in FDA regulations. The position entails preparing regulatory documents, supporting audits, reviewing dietary supplement labels for compliance, and coordinating with internal teams and external partners to gather

Qualifikationen

• Bachelor's degree in Regulatory Affairs, Food Science, Chemistry, Biology, or related field.
• Minimum 3 years of hands-on U.S. regulatory affairs experience in dietary supplements or related industries.
• Strong working knowledge of FDA regulations, including 21 CFR Parts 111 and 117, and FSVP.
• Experience preparing regulatory documentation and reviewing FDA-compliant dietary supplement product labels.
• Experience supporting regulatory audits, certifications, and compliance documentation.
• Ability to work independently and manage regulatory responsibilities with limited supervision.
• Must be legally authorized to work in the United States.

Aufgaben

• Prepare, review, compile, and submit required regulatory documents, registrations, notifications, and supporting technical dossiers in accordance with applicable U.S. regulations.
• Support regulatory audits and certifications, independently preparing and maintaining compliance records.
• Review and approve finished dietary supplement product labels for compliance with FDA labeling regulations.
• Coordinate with internal departments, external laboratories, suppliers, customers, and regulatory agencies to obtain necessary documentation and supporting information.

Kenntnisse

Regulatory affairs

FDA regulations

FSVP

Ausbildung

Bachelor's degree in Regulatory Affairs

Jobbeschreibung

Regulatory Affairs Manager (Part-Time)

Location: Santa Ana, CA – On-site
Employment Type: Part-Time Only
Schedule: Approximately 12–16 hours per week

About Huisong Inc.

Founded in 1998, Huisong Pharmaceuticals specializes in the research, development, and manufacturing of natural ingredients for the pharmaceutical, nutraceutical, food and beverage, and personal care industries.

Huisong Inc., our U.S. operation based in Santa Ana, California, is seeking an experienced, hands‑on Regulatory Affairs Manager to support regulatory compliance for botanical ingredients, natural products, and dietary supplements.

Official Company Website: https://www.huisongpharm.com/

Key Responsibilities:

• Prepare, review, compile, and submit required regulatory documents, registrations, notifications, and supporting technical dossiers in accordance with applicable U.S. regulations.
• Support regulatory audits and certifications, independently preparing and maintaining compliance records.

• Review and approve finished dietary supplement product labels for compliance with FDA labeling regulations.
• Coordinate with internal departments, external laboratories, suppliers, customers, and regulatory agencies to obtain necessary documentation and supporting information.

Qualifications:

Required:

• Bachelor's degree in Regulatory Affairs, Food Science, Chemistry, Biology, or a related field.
• Minimum 3 years of hands‑on U.S. regulatory affairs experience in dietary supplements, food ingredients, or related industries.
• Strong working knowledge and practical experience with FDA regulations, including 21 CFR Parts 111 and 117, and the Foreign Supplier Verification Program (FSVP).
• Demonstrated experience preparing regulatory documentation and reviewing FDA-compliant dietary supplement product labels.
• Experience supporting regulatory audits, certifications, and compliance documentation.
• Ability to work independently and manage regulatory responsibilities with limited supervision.
• Must be legally authorized to work in the United States.

Preferred:

• Experience with USDA Organic / CCOF certification and compliance requirements.
• Experience working with botanical extracts, natural ingredients, or finished dietary supplements.

Work Arrangement:

• Part-time only: approximately 12–16 hours per week.
• On-site work in Santa Ana, California is required.
• Candidates must be able to work independently and provide practical regulatory support within the part-time schedule.

We welcome experienced regulatory professionals seeking a long-term, part‑time opportunity.