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Regulatory and Quality Manager New


5 Star Nutrition


Austin, United States

United States





Not specified

Permanent | Full Time

Who are we and what are we about:Defyned Brands is a premier developer, marketer, distributor and multi-channel retailer of best-in-class vitamins, supplements and apparel. Originally founded as a specialty retailer with one location, the company has grown to own and operate 50+ 5 Star Nutrition specialty supplement stores, five nationally recognized vitamin and supplement brands and over 200 employees all driven by the same mission: To deliver outstanding results for our customers. We are dedicated to the ultimate customer service experience & company culture is the centerpiece of our company which has been the foundation of our success.What we need:Defyned Brands is seeking a Regulatory & Quality Manager to lead the development and execution of strategic initiatives related to domestic and international regulatory and quality assurance. This role, reporting to the Chief Innovation Officer, will work closely with internal stakeholders including Product Development, Marketing, Sales and Supply Chain functions and external stakeholders including suppliers and contract manufacturers to ensure that we meet FDA, FTC and other domestic and international regulatory requirements and conform to the highest quality standards relating to the development, manufacturing, marketing and distribution of dietary supplements. We are looking for an inpidual with a strong scientific background with experience in the regulation of Foods & Dietary Supplements in the United States and/or International markets.What youll do:* Develop and execute regulatory strategies to create competitive advantage and ensure compliance of labels, formulations and marketing collateral with domestic, international, marketplace and other regulations* Establish and ensure processes and procedures are fully compliant, audispan and meet all local, state and federal Regulatory and Company requirements* Partner with Sales organization, consultants and distribution partners to understand international expansion efforts and pertinent dietary supplement and food regulations set forth by respective regulatory authorities* Prepare and submit appropriate documentation and responses to FDA, FTC and other Regulatory bodies in a timely manner* Act as functional expert in ensuring compliant labeling and play lead role in reviewing labels, marketing material and website content against supporting documentation to ensure claim substantiation* Maintain marketing and advertising substantiation files* Conduct or review and approve vendor, supplier, contract manufacturer, etc. qualification, audit, monitoring and verification efforts* Organize and execute in-house quality audits and continuous improvement efforts* Develop and maintain raw material and finished good specifications in collaboration with supply chain and contract manufacturers* Establish processes to track, analyze and lead initiatives for all internal quality and customer complaint issues and adverse events* Establish and maintain quality management documentation including routing, review, approval, distribution and archival of controlled documents* Oversee third-party testing programs and protocol development* Drive step-function organizational change through ownership of Objectives and Key Results (OKRs) aligned with the Companys strategic goalsHow you will excel:* You will be a passionate, high energy, highly motivated self-starter who enjoys working in a fast-paced, high-growth and dynamic environment* You will have strong knowledge of domestic and/or international regulatory environment* You will stay up-to-date on FDA, FTC and other regulatory authorities regulations and policies* You will have robust knowledge of FDA cGMP* You will have thorough understanding of methodologies relating to quality assurance and standards* You will be a strategic thinker with excellent problem solving and project management skills with ability to manage complex regulatory issues affecting products, ingredients, labels and packing, and policy initiatives* You will use strong analytical skills to leverage data and statistical methods to drive decisions* You will have a keen attention to detail and practice exceptional organization* You will have strong technical writing abilities along with excellent communication skills with ability to explain and propose solutions to complex regulatory and/or quality issues to stakeholders and throughout all levels of the organizationWhat experience is desired:* 5+ years of domestic and/or international regulatory experience, preferably within a food, dietary supplement or consumer packaged goods regulated environment* Bachelors degree or equivalent in food science, life science, engineering or similar field* Experience with and strong knowledge of Dietary Supplement Regulations* Experience in direct interaction with FDA, FTC and other domestic/international regulatory authorities* Experience navigating state regulations such a Californias Proposition 65 preferred* Experience in Sports Nutrition a plusDefyned Brands offers a very competitive compensation & benefit package that includes: quarterly bonus potential, flexible work arrangements, company sponsored health, dental & vision insurance; life and long-term disability insurance, unlimited free snacks, beverages and cold-brew coffee, generous product employee discounts, team social events, onsite gym & a casual high energy working environment.Defyned Brands is an Equal Opportunity Employer. This description represents the job in general terms and is not designed to contain or to be interpreted as a comprehensive listing of all the duties, responsibilities, and qualifications required of the employee performing this job.

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