Product Regulatory Specialist

Product Regulatory Specialist

The Product Regulatory Specialist 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 Research & Innovation 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.

• 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.
• Evaluate ingredients, raw materials, and formulations based on risk assessments conducted and communicate safety approvals.
• Create regulatory data for all ingredients and raw materials including SDS authoring and product regulatory review for compliance.
• Code new raw materials and formulas into internal ERP and Lab Management Systems.
• Compile, catalog, and archive documentation to support the regulatory requirements.
• Compile and submit new formulas for regulatory filing with the FDA and other regulatory bodies.
• Interface and collaborate with appropriate R&I team to support global compliance assessment of new raw materials and formulas.
• Prepare and support regulatory product submissions or registrations globally for cosmetic, hair care, skin care and OTC products.
• Develop and implement regulatory strategies for launching new products and maintaining existing products.
• Ensure products placed on the market comply with local, country, and/or federal regulations.
• Proactively monitor changes in the regulatory environment and provide insights and recommendations on how to address them appropriately.
• Work collaboratively with R&I, Engineering, Operations, and Supply Chain to evaluate risks and provide risk assessments to the key stakeholders.

Qualifications

• Relevant regulatory affairs expertise in the cosmetic, OTC, or consumer/personal health care industries.
• Demonstrated experience in the preparation and submission of regulatory documents.
• Excellent communication (verbal, written) and interpersonal skills required.
• Experience working with OTC products.
• Solid organizational skills and flexibility to manage multiple projects simultaneously in a fast-paced highly matrixed environment while meeting established deadlines.
• Experience with ERP or LMS such as Sage X3 or Formulator.

• BS in Regulatory Affairs, Chemistry, Biology, or related science.
• 5 years of experience in cosmetics, personal care or consumer healthcare industries.
• Thorough familiarity with global regulations for cosmetics and OTC products.
• Must have a strong understanding and knowledge of US and international cosmetic regulations/ US Food & 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.
• Demonstrated skills in analyzing, reporting, and documenting information with attention to detail.
• Knowledge of quality, cGMP, FDA and OSHA regulations.

• Must be able to climb stairs, stand for periods of time and have the ability to bend, squat, kneel, turn, and stoop.
• Requires some walking, as well as sitting for periods of time.
• Ability to work and function safely in a Laboratory environment.