Sr Regulatory Affairs Specialist at Lanxess Corporation
Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Pittsburgh, Pennsylvania
Who we are:
LANXESS is a leading specialty chemicals company with sales of EUR 7.7 billion in 2016 and about 19,200 employees in 25 countries. The company is currently represented at 75 production sites worldwide. The core business of LANXESS is the development, manufacturing and marketing of chemical intermediates, additives, specialty chemicals and plastics. Through ARLANXEO, the joint venture with Saudi Aramco, LANXESS is also a leading supplier of synthetic rubber. LANXESS is listed in the leading sustainability indices Dow Jones Sustainability Index (DJSI World) and FTSE4Good.
In the United States, LANXESS employs approximately 2,150 people at 23 locations in 12 states.
What we can offer you:
LANXESS is a young company with strong roots! We derive our strength from global presence, management excellence and most importantly our people! Our employees are the pillars of our success.
We offer exciting career opportunities regionally as well as internationally, educational assistance programs, competitive pay and benefits, language training programs, and many other personal and professional development programs that are a part of our vision and values that drive our ongoing success.
As a Senior Regulatory Affairs Specialist you will:
· Ensure LANXESS compliance with the Federal Food and Drug Administration (FDA) regulations and requirements regarding food contact substances, food and animal feed additives, and medical devices, and provisions of the Bioterrorism Preparedness and Response Act
· Provide responses to internal (North America and Europe) and external customer requests for food contact clearances, NSF support, Kosher certifications, and related topics. Provide advice and expertise on regulatory matters with regard to food contact materials and drinking water in the US to the Business Units in the US and Germany. Coordinate Canadian Food and Drug Act clearances
· Coordinate necessary physical testing and legal consultations to determine applicable FDA clearance; contract mammalian toxicity, genotoxicity and ecotoxicity testing to assess product safety
In order to accomplish this you will:
· Possess a minimum of a Master's degree in chemistry or toxicology (preferably American Board of Toxicology certified)
· Possess 5 years of applicable Food and Drug regulation experience
· Demonstrate technical knowledge of current regulatory requirements under the FDA
· Exhibit individual problem-solving skills necessary for evaluating product chemistry and potential health hazards of products relating to the FDA food contact clearances
· Display strong interpersonal skills in order to provide effective customer service even when working under tight time constraints
· Possess the ability to communicate with all levels of management throughout LANXESS and to relate proactively with customers and other companies, governmental, and non-governmental organization representatives
· Possess working knowledge of Microsoft Office software
Must include a resume.
LANXESS is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status or disability.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor s legal duty to furnish information.