Director of Regulatory Affairs in Countryside,IL,US

Summary:• The Director of Regulatory Affairs develops, coordinates, and implements regulatory strategies for products that require government approval. Prepares marketing applications required by the government to obtain approval for regulated products. Coordinates government interactions and compliance activities and interacts with regulatory agencies. Supervises the development of procedures and controls to ensure organizational compliance.Essential Duties and Responsibilities include the following.• Develops strategies to ensure regulation compliance.• Directs the preparation and submission of regulatory agency applications and correspondence.• Reviews all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.• Manages activities such as audits, regulatory agency inspections, or product recalls.• Formulates or implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.• Prepares Safety Data Sheets and related DOT regulatory documentation.• Maintains current knowledge of relevant regulations, including proposed and final rules.• Provides regulatory guidance to department and communicates regulatory information to ensure that information is interpreted correctly, and requirements are met.• Provides responses to regulatory agencies and customers regarding regulated product information or issues.Required Skills/Abilities:• Bachelors degree, B.S., in Chemistry or Industrial Engineering.• A minimum of 3 years of experience in regulatory affairs including FIFRA, Hazardous Material Regulations, Dangerous Goods, and familiarity with international regulations such as REACH-ECHA.• Impeccable knowledge of regulations. Maintains a current knowledge of relevant regulations, including proposed regulatory legislation and guidelines.• Strong time management skills.• Effective communication skills to keep managers and department heads informed of regulations and policies they must comply with.• Problem solving and strategic planning skills for change procedures in order to comply with regulations and develop an action plan to move the company into compliance.• Teamwork skills are required to provide education to members of the team for regulatory training and compliance.Physical Demands:• Prolonged periods of sitting at a desk and working on a computer.• Exposure to various chemicals and compounds.• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee may have contact with fumes or airborne particles and hazardous or corrosive chemicals. The noise level in the work environment is usually moderate.