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Regulatory Affairs /Compliance Manager

Company: Vit Best Nutrition
Location: Tustin
Posted on: March 20, 2020

Job Description:

Position Summary The primary purpose of this position is to ensure formulas, supplement facts, and label claims, of Vit-Best's nutritional products meet Regulatory Affairs requirements. The position is also responsible for overseeing the overall compliance activities and reporting, including the handling of external audits, product complaints, and adverse events. Responsibilities Manage the process for Supplement/ Nutrition Facts and claim benefits as well as ingredient disclosures, allergens, and other attributes for overall compliance related to product labeling, registration, and licensing. Oversee and confirm scientific claims substantiation and licensing process for VBN products. Approve VBN label/labeling and product disclosures to ensure regulatory compliance. Manage all product claim and supplement fact activities including proof reading, creating, reviewing, and approving finished product label artwork. Work closely with R&D, Sales, and other related departments on new product launches and international registrations. Responsible for establishing appropriate Hold Harmless Agreements for VBN as well as providing input for Quality Agreements and Contracts. Manage raw material and ingredient composition review and labeling process per regulation guidelines. Ensure formula assessments with Master Manufacturing Record (MMR) and Finished Product Specs (FPS) are correct. Ensure regulatory standards and protocols for compliance with FDA, FTC, DSHEA, and other related agencies and authorities are being met. Effectively manage timely label creation, revision, and release process. Confirm Product Data Sheet (PDS) going to customer for completeness and accuracy. Ensure the handling, storage, and disposition of all labels follow regulations as per 21 CFR. Research and stay current with changing regulations and serve as in-house regulatory affairs subject matter expert. Oversee Regulatory & compliance personnel in providing structure, training, and objectives as well as performance reviews. Responsible for reviewing responses to official customer inquiries and correspondence with government agencies to ensure that they are complete and proper. Develop internal controls and policies designed to ensure that compliance needs are met. Work closely with department managers to review departmental policies for compliance issues. Manages external audit program, including hosting onsite 3rd party and regulatory agency audits, managing corrective and preventative response reports, and working with other department heads to improve processes that come from audit findings. Train and lead compliance associates in the areas of root cause analysis and corrective actions. Lead compliance team in mock recalls and internal audits. Assist QA, QC, and Account Management with customer audits as needed. Perform other tasks as assigned by management. Qualifications Minimum 5-10 years Labeling experience of dietary supplements required. Excellent knowledge in regulatory and technical aspects. Knowledge of Food and Drug Administration regulations and guidelines including 21 CFR. Strong knowledge of dietary supplements/Food Industry, Packaging, and cGMPs preferred. Excellent with Microsoft Office including Word, Excel, Outlook. Ability to write formal business reports. Education & Experience Bachelor of Science Degree (BS) in Food Science or other related field with minimum of 7 years of related experience and/or training. Master of Science Degree (MS) in Food Science is desired with 5 years of related experience. Minimum 5 -10 years with dietary supplements and related experience and/ or training in Regulatory Affairs within dietary supplements. Certification in Regulatory Affairs is desired.

Keywords: Vit Best Nutrition, Tustin , Regulatory Affairs /Compliance Manager, Executive , Tustin, California

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