We currently are seeking a dynamic, strategic, and innovative Regulatory Affairs Specialist. This key position will be based in our corporate offices in Northridge, CA (Southern CA).
For more than 40 years, Pharmavite has been a trusted leader in the wellness industry, recognized for providing quality vitamins, minerals and supplements and all natural snacks under our Nature Made® and SOYJOY® brand names. Our mission: People creating new products for better health worldwide. Our vision: Inspiring the healthiest you through more complete nutrition…Wherever you are in life. As a member of the Pharmavite team, employees enjoy competitive salaries and an exceptional benefits package featuring medical, dental, vision, 401K, life insurance, and long term disability coverage. In addition, employees enjoy educational assistance, credit union membership, substantial discounts on our products, and 11 paid holidays per year.
Purpose of Job:
Responsible for ensuring that the domestic and/or international regulations are met, helps establish and maintain procedures and processes to ensure regulatory compliance and helps the regulatory function to provide support to enable Sales and Marketing to continue to sell current in-market products or launch new products. This position also assists in the regulatory approval of labeling artwork, advertising, product claims and packaging standards for such products.
Essential Responsibilities and Duties:
Responsible for the preparation of registration applications and other regulatory submissions related to dietary supplements and/or health foods to be sold in the domestic or international markets.
Prepares regulatory-mandated label copy for dietary supplements and/or health food products. Proof-reads and approves label artwork and bulk labels based on research and interpretation of product formulas, applicable regulations, contract provisions, account preferences and Pharmavite policies. Monitors formula changes and label revisions to assure compliance with domestic and foreign regulatory requirements.
Monitors, analyzes and assures compliance with regulatory requirements for the registration or premarket or import clearance of dietary supplements and/or health products in the domestic or international markets and is responsible for the preparation and tracking of internal and external documentation associated with product registrations, premarket, import clearance and post market surveillance.
Creates MBRs, BOMs, LRRs, formula breakdowns, etc. and manages the approval process of all applicable regulatory requirements. Manages regulatory project timelines, product registration and ingredient databases
Prepares packaging standards that accurately reflect required packaging components, labeling and bulk product (including appropriate revision levels).
Works with regulatory bodies and consultants, acting as a liaison to prepare, assess and submit product registration dossiers and other regulatory submissions related to international products for the purpose of registering Pharmavite products.
Oversees the submission of applicable documents through appropriate U.S. agencies for their legalization by applicable consulates/embassies. Updates product registration status by country.
Responsible for handling any maintenance "ad hoc" projects due to label revisions initiated by Sales/Marketing or new regulatory changes.
Performs other related duties as assigned.
Bachelor's degree in a scientific field (Chemistry, Biology, Nutrition, Food Science, or related field, etc.) is required. Master's Degree is preferred.
Regulatory Affairs Certificate (RAC) preferred.
Two to three years' domestic or international regulatory experience with a preferred emphasis in dietary supplements, health foods or pharmaceutical products.
Knowledge and understanding of domestic and/or foreign country dietary supplements regulations.
Experience in compiling regulatory documents and working with outside consultants to file applications for registrations of dietary supplements, health foods or pharmaceuticals with relevant government agencies.
Collaborate in meetings with multiple stakeholders in a cross functional team setting. Must be able to represent regulatory interests in an interactive team environment.
Foreign language skills, especially Chinese, Korean, Arabic or Spanish, is preferred to support international markets.
Strong analytical and good oral and written communication skills.
Proficiency in word processing, spreadsheet and graphic presentation software including but not limited to Microsoft Office applications (Word, Excel and PowerPoint, Access).
Familiarity with MS Project and R.A.C.I. process is desirable.
High degree of flexibility, organization and detail-oriented.
Effectively handle and complete multiple projects simultaneously in a timely manner.
General office environment. Long periods of sitting.
Exposure to disagreeable elements is negligible.
The incumbent must be able to perform this job safely without endangering the health or safety of self or others.
Pharmavite is proud to be an equal opportunity and affirmative action employer. F/M/Disability/Vet
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