Regulatory Affairs Manager

Regulatory Affairs Manager

Santa Ana, CA Part-time Approximately 20-25 hours per week

Founded in 1998, Huisong Pharmaceuticals specializes in the R&D and manufacturing of premium-quality natural ingredients for world-leading companies in the pharmaceutical, nutraceutical, food & beverage, and personal care industries. Today, Huisong Pharmaceuticals is a global operation with an extensive and dynamic product portfolio of natural products and ingredients, remaining firm in its values of "Nature, Health, Science", and continues to advance the world of medicine and nutrition for the well-being of humanity.

Job Description

• Develop and execute global regulatory strategies for new and existing products (e.g., dietary supplements, herbal extracts, TCM).
• Lead FDA submissions (e.g., NDIN, GRAS, OTC monographs) and international registrations (e.g., EU Novel Food, Health Canada NHP).
• Advise senior management on emerging regulations (e.g., FDA's NDIN updates, Prop 65, FSMA).
• Ensure compliance with cGMP, 21 CFR 111/117, ISO 9001, and organic certifications (USDA, EU).
• Manage regulatory audits (FDA, NSF, customer audits) and lead corrective actions.
• Oversee labeling and claims review per FDA/FTC guidelines (e.g., structure/function claims, TCM disclosures).
• Collaborate with R&D, Sales, and Supply Chain to align regulatory requirements with business goals.
• Liaise with global suppliers to ensure raw material compliance (e.g., adulteration testing, heavy metals, pesticide limits).
• Navigate TCM-specific regulations (e.g., USP Herbal Compendium, WHO guidelines, China NMPA standards).
• Address challenges in botanical adulteration, safety data, and traditional use claims.

Education and Experience Requirements

• Bachelor's degree or equivalent in pharmacy, chemistry, food science, or herbal medicine; RAC certification a plus.
• 5+ years in regulatory affairs (nutraceuticals, botanicals, or TCM).
• Deep knowledge of: FDA 21 CFR 111/117, DSHEA, NDIN, GRAS, cGMP, ISO9001, FSVP, and global supplement regulations.
• PCQI (Preventive Controls Qualified Individual) certification required ; HACCP certification or related food safety training is a plus.