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Regulatory Affairs Specialist
1 month ago
About Inari... Inari is the SEEDesign company. We embrace the diversity and complexity of nature in every aspect of our business to drive innovation - to push the boundaries of what is possible. Through our unrivaled technology platform, Inari uses predictive design and advanced multiplex gene editing to develop step-change products. We are taking a nature positive approach to unlock the full potential of seed that will transform the food system. The results will lead to more productive acres delivering value creation for farmers and a more sustainable future for our planet. Our success is dependent on great minds, collaborating to generate bright ideas and deliver exceptional outcomes. We have over 300 employees, with research sites in Cambridge, MA (USA) and Ghent (Belgium), as well as a product development site in West Lafayette, IN (USA). We've deliberately built a team that brings diversity of thought to all aspects of our business, to generate new ideas, approaches, and ways of operating. And we've intentionally combined experience with potential, bringing agriculture industry experts with the desire to innovate together with bright minds from academia, human therapeutics, software, and consulting. If you want to be part of a diverse and inclusive team developing unique solutions to feed the world while protecting our planet's natural resources, we'd love to hear from you About the role.... As the Regulatory Specialist, you will be responsible for support in the tracking and execution of the overall regulatory plan to obtain needed authorizations for commercialization. This role provides operational support for submissions and consultations and helps to ensure data availability is timely and according to the quality requirements including Genetically Modified Organisms (GM post patent and Gene-edited GM) and Gene-edited products. This role is based in West Lafayette, IN or Cambridge, MA and reports to the Director of Regulatory. As the Regulatory Specialist, you will... Closely collaborate cross functionally, to ensure Regulatory Plans are tracked to support Inari technologies Support creation of Regulatory Project Plans with timelines including launch considerations for cultivation and import of Inari Technologies including Gene-edited and Genetically Modified products Align and collaborate with Regulatory Science to ensure data is generated and available for submissions and consultations according to plans Track and manage documentation for the Regulatory Project Plans including agency consultation, managing agency submissions and obtaining authorization according to plan for Gene-edited and GM products Support submission and/or consultations with regulatory authorities both local and global Support variety registration when applicable and verify data needs and generation. Manage filing as needed in collaboration with legal Operational support execution of state registrations and submissions Support applications/consultations for Field and Counter Season permits as appropriate to enable testing and seed increases Support Regulatory Intelligence activities and tracking evolution of data requirements and regulation frameworks at a global level Monitor Regulatory competitor activities and access to information where available. Manage the internal access to such information Work closely with other Regulatory functions (such as Regulatory Science and Regulatory compliance) and engage proactively in business-partnering with the Science, Product and Commercial organizations. You Bring... Solid experience in biological sciences, preferably agricultural sciences, or related disciplines; Minimum BS degree, MS degree desirable 3-5 years of work experience in agricultural or microbial biotechnology At least 3 years work experience supporting laboratory, greenhouse, and field operations Experience interacting with Regulatory agencies, including but not limited to USDA, EPA, and US state agencies is a plus Self-starter, pro-active communicator, and highly organized working style Ability to work quickly to meet tight deadlines and assure Inari's freedom to operate A strong sense of purpose and drive to develop unique, high impact solutions Adaptability and enthusiasm for new challenges, innate curiosity, and a passion for learning Creative and strategic thinking, willingness to be bold and take risks, and the ability to recognize and learn from failure A collaborative mindset that is open to giving and receiving ideas, perspectives, and feedback Ability to work independently while embracing the company values and culture, and to deliver on responsibilities within a highly collaborative environment Ability to effectively communicate with a diverse range of individuals and audiences FOR U.S. CANDIDATES: Please note that we use the resume you submit with your application during our background check process. To ensure an efficient and accurate background verification, we kindly ask that you carefully review and accurately represent your work history, education and other relevant information on your resume. Any discrepancies or inaccuracies found during the background check may impact your candidacy for the position. #J-18808-Ljbffr
