Product Regulatory Specialist

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      "role": "<meta><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"font-size:18pt;white-space:pre-wrap;\">Position Summary</strong></b></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">The </span><b><strong style=\"white-space:pre-wrap;\">Product Regulatory Specialist</strong></b><span style=\"white-space:pre-wrap;\"> is responsible for the safety evaluation and documentation of raw materials and finished formulations developed by, or acquired by BMSC, in compliance with global regulations and guidelines. This is a technical position that will require in-depth working knowledge of toxicology and safety risk assessments, experience in problem solving, and execution of tasks related to approval of raw materials and finished formulations developed by BMSC prior to market launch. The position supports the Regulatory and Compliance department and works cross functionally with Quality, Sales, and Engineering, ensuring company compliance with local, state, federal, and international regulations associated with manufacturing and marketing cosmetic, hair care, skin care and Over-the-Counter (OTC) products. They assess new/upcoming regulations impacting BMSC, provide appropriate risk assessments, evaluate their impact and make recommendations.</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><br></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><i><em style=\"white-space:pre-wrap;\">This position requires a full-time, five-day on-site presence at our Coppell, Texas office. Remote and hybrid work arrangements are not available.</em></i></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><br></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"font-size:18pt;white-space:pre-wrap;\">Responsibilities and Essential Duties</strong></b></p><ul data-pattern=\"discCircleSquare\" data-depth=\"1\" style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;\"><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Conduct robust safety assessments that meet global regulations on raw materials and finished formulations for a category of products (skin care, hair care, make-up) including OTC products.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Evaluate ingredients, raw materials, and formulations based on risk assessments conducted and communicate safety approvals.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Create regulatory data for all ingredients and raw materials including SDS authoring and product regulatory review for compliance.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Code new raw materials and formulas into internal ERP and Lab Management Systems.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Compile, catalog, and archive documentation to support the regulatory requirements.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Compile and submit new formulas for regulatory filing with the FDA and other regulatory bodies.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Interface and collaborate with appropriate R&amp;I team to support global compliance assessment of new raw materials and formulas.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Prepare and support regulatory product submissions or registrations globally for cosmetic, hair care, skin care and OTC products.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Develop and implement regulatory strategies for launching new products and maintaining existing products.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Ensure products placed on the market comply with local, country, and/or federal regulations.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Proactively monitor changes in the regulatory environment and provide insights and recommendations on how to address them appropriately.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Work collaboratively with R&amp;I, Engineering, Operations, and Supply Chain to evaluate risks and provide risk assessments to the key stakeholders.</span></li></ul><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"font-size:18pt;white-space:pre-wrap;\">Technical Skills Required</strong></b></p><ul data-pattern=\"discCircleSquare\" data-depth=\"1\" style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;\"><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Relevant regulatory affairs expertise in the cosmetic, OTC, or consumer/personal health care industries.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Demonstrated experience in the preparation and submission of regulatory documents.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Excellent communication (verbal, written) and interpersonal skills required.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Experience working with OTC products.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Solid organizational skills and flexibility to manage multiple projects simultaneously in a fastpaced highly matrixed environment while meeting established deadlines.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Experience with ERP or LMS such as Sage X3 or Formulator</span></li></ul><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:18pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"font-size:18pt;white-space:pre-wrap;\">Experience Required</strong></b></p><ul data-pattern=\"discCircleSquare\" data-depth=\"1\" style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;\"><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">BS in Regulatory Affairs, Chemistry, Biology, or related science.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">5+ years of experience in cosmetics, personal care or consumer healthcare industries.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Thorough familiarity with global regulations for cosmetics and OTC products.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Must have a strong understanding and knowledge of US and international cosmetic regulations/ US Food &amp; Drug Administration (FDA)/US Federal Food Drug and Cosmetic Act/US State Regulations, pertaining to the compliance and safety of practices of cosmetic and OTC products.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Demonstrated skills in analyzing, reporting, and documenting information with attention to detail.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Knowledge of quality, cGMP, FDA and OSHA regulations.</span></li></ul><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:18pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"font-size:18pt;white-space:pre-wrap;\">Physical Requirements </strong></b></p><ul data-pattern=\"discCircleSquare\" data-depth=\"1\" style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;\"><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Regularly sit, stand, and walk for extended periods of time.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Frequent exposure to varying temperatures, rain, loud noises, heavy machinery, moving mechanical parts, vibrations, fumes, airborne particles, electrical, and chemicals.</span></li><li style=\"font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Prolonged use of computer screen.</span></li></ul>",
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