Regulatory Affairs Specialist

Alhambra, CA, US, United States

Job Description

Summary

Dragon Herbs is a fast growing, vertically integrated dietary supplement company with retail outlets, mail order and e-commerce divisions. We offer one stop shopping to our customers by providing practitioner consultation services in addition to our branded products.

Do you have a passion for SOP's. Have you overseen production in the dietary supplement world? Experience with the FDA and cGMP? Then we want to speak to you! Respected and established player in the dietary supplement industry is looking for a

Regulatory Affairs Specialist

to join our team. The work is meaningful, fulfilling and on the cutting edge of health and wellness.

Responsibilities



1. Regulatory compliance



Ensure compliance to FDA dietary supplement and food regulations in the areas of manufacturing, labeling, documentation Maintain and/or compose cGMP compliant SOP Standard Operating Procedures.

2. Production



Vendor relations: new vendor vetting, Annual vendor facility audits On-going purchase order coordination with vendors and production documentation review such as batch records

3. QC-Quality Control



Oversee testing in US and China of raw material and finished products using methods such as HPLC, DNA, TLC, chromatography, organoleptic analysis, etc. Review, translate, and organize reports and COA Certificates of Analysis for quality control purposes

4. Product claim substantiation based on scientific and historical publications of herbal ingredients



5. Internal and external practitioner training program content contributor



Keep abreast of the latest TCM developments in China and US Monitor, research, summarize and translate from Chinese to English Traditional Chinese Medicine TCM print and online publications such as Wanfang Data, China Journal of Traditional Chinese Medicine and Pharmacy, China Journal of Chinese Materia Medica, Global TCM, International Journal of TCM, Traditional Chinese Medicine Physiology and Clinical Applications, etc. Monitor, research, summarize US herbal trade journals, acupuncture journals and scientific literature from PubMed, FDA, NIH National Institute of Health, WebMD, etc. Contribute medical scientific write-up for the internal and external continuing education of TCM/Acupuncture practitioners

6. Archival of pertinent scientific and historical literature in both English and Chinese into company proprietary databases for expedient retrieval and search.



7. Research & Development of new products



Qualifications and Requirements



Must have at least a Bachelor's Degree in Food Safety, Biology, Chemistry, Clinical Nutrition, or Traditional Chinese Medicine. Familiarity with Chinese Herbs and Herbology helpful, but not required Meticulous attention to detail

Computer/Technical Skill



Excellent computer skills with advanced knowledge of the MS Office suite: MS Word, Excel, Outlook, PowerPoint. Database knowledge a plus. Touch type 50 WPM

Working Conditions



Full time position. Mon-Fri 9 am to 5 pm. Work must be completed on site at our office in Alhambra, CA Work with other like-minded, super smart people advancing the field of Traditional Chinese Medicine and Herbology in the US Pay: Negotiable depending on relevant experience.

Notes



The above information has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

We are an equal opportunity employer

Job Type: Full-time

Pay: From $30.00 per hour

Expected hours: No less than 40 per week

Benefits:

Dental insurance Health insurance Paid time off Vision insurance
Education:

Bachelor's (Required)
Work Location: In person

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Job Detail

  • Job Id
    JD5566186
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    USD
  • Employment Status
    Permanent
  • Job Location
    Alhambra, CA, US, United States
  • Education
    Not mentioned