Regulatory Affairs Specialist for an R&D organization located here in Columbus, Ohio
Great Full Time Direct Hire with a fabulous organization!
Salary is based on experience!
The Regulatory Affairs Specialist provides support both domestically and internationally (US, Canada, EU & other regions) and ensures policies, procedures, and processes are in compliance with all applicable regulated requirements. This position works closely with customers and internal departments to prepare and maintain regulatory submissions for new products, product changes, as required to ensure continued compliance, and timely approval for market release of products.
- Organizes and maintains regulatory files and databases to ensure prompt and accurate access to regulatory information for raw materials and formulas.
- Reviews and confirms formula acceptability in accordance to the guidelines set by the applicable countries and/or customers.
- Reviews and/or creates formula listings, ingredient lists, and other regulatory documents.
- Requests and reviews supporting technical and non-technical data from raw material vendors.
- Develops a regulatory compliance process that focuses on internal controls, process efficiency and standardization, and product integrity.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates
- Provides regulatory guidance to product development teams and responds to product information requests
- Provides marketing team with regulatory support in developing product profiles, ensuring claims are appropriate for cosmetics, and can be supported by formula.
- Ensures that regulatory requirements are met for products prior to presenting to customers for submission and/or presentation.
- Prepares and submits Equivalent Raw Material Forms.
- Obtains and maintains relevant regulatory subscriptions, including PCPC, FDA, Cosmetic Design, etc.
- Develops and/or updates Standard Operating Procedures (SOPs), policies, and other materials related to regulatory compliance. Documents and communicates any new or updated materials to all affected departments to ensure related databases are accurate and up-to-date.
- Bachelor of Science Degree in Chemistry or other related field. In lieu of degree, a combination of education and experience in the cosmetics/personal care industry considered.
- Minimum of two years in a regulatory role required, preferably in the cosmetic/personal care industry.
Please click apply to be considered or email firstname.lastname@example.org to be considered immediately.
No relocation fees will be applicable so only local candidates will be considered. Must be authorized to work in the U.S.