Our client is a manufacturer of beauty products based in Stone Mountain, GA. Our client is seeking a Regulatory Compliance Manager to join their team.
This position reports to the Director, R&D. The Regulatory Compliance Manager is
responsible to insure that products manufactured and/or sold by client are in regulatory compliance with local, state and Federal regulations in
the U.S. and that products sold outside the United States conform to the applicable
regulations in the country or region where they are sold.
For products sold in the United States, insure that products only contain raw materials that are not prohibited in any state or under federal regulation. If a product contains a restricted material, insure that its use meets the guidelines that have been established.
Insure that the operational aspects comply with FDA Guidelines for Cosmetic manufacture by reviewing, adding and modifying SOP’s. Collect SOP’s into a Quality assurance manual.
For products sold in the United States, maintain documentation of the WERCS review process for retailers, submit new products to WERCS for evaluation and send WERCS
evaluations to new Retailers as appropriate.
For products sold in the United States, complete additional studies as required by states such as the California VOC study.
Coordinate with ICMAD in order keep client current on cosmetic issues. Complete CIR surveys as requested.
For products sold outside the United States, insure the products are properly registered in the country of sale, submit all documents required for product registration in a country
new to client and maintain Certificates of Free Sale on a routine basis.
For products sold in the EU, work with client’s responsible person to insure that complete portfolios are created and maintained on all products sold to EU countries. Develop documentation to support product claims consistent with EU requirements. Maintain client’s database of formulas, raw material information, Stability and Preservative Efficacy Tests.
For products sold in the EU, monitor REACH compliance and determine on a yearly basis,
the amount of raw material entering the EU under the REACH program. Insure REACH monitored items are purchased as REACH compliant materials and have a REACH compliance certificate on file.
Quality Audit – Conduct periodic audits to document Regulatory compliance.
For all products generate and maintain GHS compliant Safety Data Sheets files.
For all products, generate and maintain accurate ingredient statements based on current INCI nomenclature in Laboratory and Kallik label software databases.
Other duties as assigned by the Director, R&D.
Maintain a safe and satisfactory work area as determined by OSHA and company guidelines and procedures.
Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
Problem Sensitivity - The ability to tell when something is wrong or is likely to go wrong. It may not involve solving the problem, only recognizing there is a problem.
Selective Attention - The ability to concentrate on a task over a period of time without being distracted.
Information Ordering - The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures,
Language Skills - Ability to read and interpret documents and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of
customers or employees of organization.
Mathematical Skills - Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Understand the concept of percent. Have
knowledge of statistical concepts.
Reasoning Ability - Ability to apply common sense understanding to carry out instructions
furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Ability to effectively utilize computer programs such as Microsoft Excel, Microsoft Word, Adobe Acrobat, Microsoft Dynamics and Vicinity Manufacturing.
EDUCATION AND EXPERIENCE:
Bachelor’s degree in an appropriate discipline or equivalent experience.
Several years’ regulatory experience, domestic and international.
Bilingual (Spanish) a plus
WORK ENVIRONMENT AND PHYSICAL DEMANDS:
Generally an office environment however occasional work in a non-climate controlled warehouse/manufacturing environment with machine and production line noise.
Ability to stand, walk, sit, squat, bend, and climb.
Ability to lift and carry up to 50 pounds
Ability to see details at close range (within a few feet of the observer)