Job: Regulatory Affairs Associate (On-Site at Client), knoellUSA, Research Triangle Park, NC
knoell is a global company headquartered out of Germany that researches, processes and evaluates scientific data across all scientific specialties. Our vision is to be the trusted industry leader in worldwide regulatory solutions. We compile registration dossiers and submit them to national and international authorities. The size of our company allows us to act as a full service provider and assemble a team of the required size and expertise to serve clients in agrochemical, biocides, industrial chemicals, product safety, veterinary medicine and medical devices.
knoell USA is part of an extensive network of scientific and regulatory experts who partner with major multi-national, mid-tier and start-up clients. Services include scientific consulting, analytical services, technical writing, and document management services with offices in Pennsylvania, North Carolina, and Tennessee.
The Regulatory Affairs Associate is responsible for managing all aspects of Regulatory Affairs projects as assigned by the client and for working as part of the client’s team. This is an embedded role, where the knoell Regulatory Affairs Associate works on-site at a client once regular work arrangements resume post-COVID. The Regulatory Affairs Associate is responsible for fostering a high level of quality and performance and will support the client. The Regulatory Affairs Associate will report to the Group Leader of Regulatory Affairs for Crop Protection & Nutrition.
? State registration document management support (e.g., product application forms, licenses, and renewals) for products regulated under FIFRA
? State registration document management support for fertilizers/soil amendments and biological products
? Assisting with the creation of NVA numbers for new and revised technical labels, and locating most current versions available of these, as needed
? Tonnage reporting for fertilizer products
? State label submission support (e.g., label amendments and quality control checks)
? 6(a)(2) reporting
? Creating special local needs and emergency exemption labels (e.g., 24(c), 2(ee), and Sec. 18)
? Maintaining databases regarding state submissions and various regulatory processes
? Regulatory monthly status reports/updates
? Other related work as requested
? Degree in biology, natural resources, chemistry or related discipline
? At least 3 years professional experience in the registration of agrochemicals in state or federal regulatory context
? Demonstrated excellent attention to detail, organizational skills and ability to prioritize work
? Excellent communication, organization and presentation skills ? Ability to work independently as well as collaboratively