Job: North America Sr. Regulatory Affairs Manager, Crop Protection & Nutrition, knoellUSA, Home Office, 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 help our clients develop registration strategies and 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 global knoell 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 North America Senior Regulatory Affairs Manager is responsible for managing all aspects of complex Regulatory Affairs projects from inception to conclusion. The North America Senior Regulatory Affairs Manager is responsible for fostering a high level of quality and performance throughout the group and will support the Group Leader of Regulatory Affairs as well as other global knoell businesses. The North America Senior Regulatory Affairs Manager will report to the Group Leader for North America Regulatory Affairs for Crop Protection & Nutrition.
? Handles project management overseeing the preparation, implementation, communication, and coordination of regulatory projects
? Serves as the client and internal point of contact on assigned projects and perform a variety of highly skilled duties such as: assembling, coordinating and managing multidisciplinary technical teams
? Manages registration projects in crop protection according to the U.S. (Federal and State), Canada, Mexico, and international regulatory frameworks
? Provides regulatory support for our clients including the execution of registration strategies and preparation of expert statements
? Develops technical documents on a variety of scientific and regulatory topics
? Serves as the go-to source of information regarding N.A. crop regulations and guidelines for clients, knoell USA staff and knoell global companies staff
? Chairs and conducts regular project meetings
? Provides excellent and timely communication with knoell team members, clients and regulatory authorities while maintaining a sense of urgency around projects and deliverables
? In coordination with the Group Leader, monitors and optimizes the capacities and workloads of the team
? Identifies project problems and corrective solutions
? Other related work as requested
? Degree in biology, natural resources, chemistry or related discipline
? 8+ years professional experience in the registration of agrochemicals in the national or international regulatory context
? Extensive experience leading projects and driving for results
? Expert knowledge of US FIFRA, PMRA and related Federal and state regulations
? Working knowledge of risk and exposure assessment
? Demonstrated excellent attention to detail, organizational skills and ability to prioritize work
? Excellent communication, organization and presentation skills
? Ability to work as a key member of a cohesive global team