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Regulatory Affairs Specialist

icon building Empresa : Partnerco
icon briefcase Tipo de empleo : Tiempo completo
icon remote-alt Remote / Work from Home

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Descripción del trabajo - Regulatory Affairs Specialist

Who Are We? Partner.Co is a global health and wellness company that partners with independent Brand Partners to help people achieve a body, business, and lifestyle they love. Through a process we call Partnership Marketing, we provide Brand Partners with everything they need to build their business, including high-demand products in the wellness, fitness, skincare, and personal care spaces, plus logistics, operations, marketing, and more. Our Brand Partners build their business by referring people to the suite of Partner.Co products are rewarded with money, travel, recognition, and fun events. Our Culture Partner.Co is a dynamic company with our Innovation Center located in Lehi, Utah, and offices around the globe. Our international presence enables our corporate staff to engage with diverse cultures as we collaborate and thrive as one high-performing, energetic team. We foster a collaborative culture where hard work is balanced with fun, and every team member's contributions are valued. Your impact matters, and we encourage all ideas! We are passionate about health and wellness! As a member of our team, you can participate in our Employee Transformation Group, where you'll receive guidance, support, and complimentary products to help you achieve your personal wellness goals. Plus, you'll have a community of friends cheering you on every step of the way! About the role Join our team as a Regulatory Affairs Specialist, where you'll play a crucial role in ensuring compliance and facilitating product registrations. You will interact with regulatory agencies to expedite approvals and serve as a key liaison among R&D, Quality, Operations, Marketing, and Sales. Your expertise will help maintain the integrity of our technical dossiers and ensure that our products meet all regulatory requirements. The preferred candidate will be located in Utah, within commuting distance of Lehi, UT; however, remote applicants from anywhere in the United States will also be considered. What you'll do Regulatory Submissions:  Coordinate the preparation and submission of regulatory documents, ensuring accuracy and compliance with applicable regulations. Agency Communication:  Serve as the primary point of contact for regulatory agencies, managing inquiries and facilitating audits. Technical Review:  Conduct thorough reviews of data and reports to ensure scientific rigor and clarity in regulatory submissions. Labeling Compliance:  Review product promotional materials, labeling, and specifications to ensure adherence to regulatory standards. Knowledge Maintenance:  Stay updated on existing and emerging regulations relevant to your markets, ensuring our practices align with current requirements. Technical File Management:  Prepare and maintain technical files necessary for product approval and compliance. Cross-Department Collaboration:  Work closely with R&D, Operations, Sales, Marketing, and Quality teams on new product launches and regulatory strategies. Customs Assistance:  Assist with customs clearance processes as required for your markets. Special Projects:  Contribute as a key member in special projects, particularly as a Greater China expert, handling various regulatory submissions and government affairs. Additional Duties:  Perform other related tasks as assigned to support the regulatory affairs function. Qualifications To excel in this role, you should possess strong interpersonal and communication skills, with a keen attention to detail. A BS/BA degree in a related field and experience in regulatory affairs are essential. Proficiency in Microsoft Office Suite is required, and the ability to review technical files with accuracy is crucial. Fluency in Japanese, Spanish, Chinese, or French is a plus. Knowledge of food/supplement and cosmetic ingredients, as well as Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Practices (HACCP), will set you up for success. Above all, we value integrity and a commitment to regulatory excellence in our team members. If you're ready to take on a pivotal role in our regulatory operations and contribute to our success, we want to hear from you!
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