Regulatory Affairs ManagerHuisong 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 117Dietary Supplement Health and Education ActNew Dietary Ingredient NotificationsGRAS requirementsCurrent Good Manufacturing PracticesISO 9001Foreign Supplier Verification ProgramsU.S. and international dietary supplement regulationsPreventive 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.
...Primary ObjectiveThe City of Bloomington is hiring election judges for the August 11, 2026, Primary Election and the November 3, 2026, General Election. Election judges play a critical role in our democracy. As an election judge, you are responsible for administering...
...Job Title: RF Test Engineer Location: San Diego, CA (Onsite) Duration : Full Time Experience: 5 7 years in RF testing, cellular modem validation, 5G NR validation, wireless device testing, or telecom productization testing. Education: Bachelor's...
...Job Description Job Description Overview: Learn a skill. Build experience. Become a skilled machine operator. Tired of production jobs where you show up, do the same thing every day, and never really learn anything new? This opportunity is different....
...Spade Recruiting is expanding its remote support team and is looking for motivated individuals to assist members in a professional... ...advancement opportunities. High school diploma required, and customer service experience is a plus. This role is fully remote and available...
...Physician Liaison Clarify Health Solutions is seeking a motivated and experienced Physician Liaison to engage directly with healthcare providers and practices to support Clarify's outcomes-based partnerships. In this role, you will guide providers/practices through...