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Regulatory Science Manager

Inari
United States, Indiana, West Lafayette
1281 Win Hentschel Boulevard (Show on map)
August 09, 2023
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 270 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! Regulatory Science Manager About the role.... The Regulatory Science Manager is responsible for creating and ensuring implementation of a data generation plan to support consultations and submissions for Inari products globally. The Manager also ensures that protocols are appropriately developed and implemented. Additional responsibilities include ensuring that data generated is aligned with the timelines and strategy for submissions and consultations. The scope includes Genetically Modified Organisms (GM post patent and Gene-edited GM) and Gene- edited products. This job reports to the Senior Director of Regulatory and is based in West Lafayette, IN or Cambridge, MA. As the Regulatory Science Manager, you will... * Create a data generation plan according to the global regulatory plan to enable consultations and submissions for Gene-edited and GMO products. * Support the organization in analyzing global regulatory data requirements. * Works closely cross functionally to ensure data generation and integrity, to be used in consultations and submissions. * Create or adapt appropriate protocols for required field and lab regulatory characterization and safety data trials. * Manage the overall data generation strategy including CRO and internal resources. * Analyze and manage budget to support regulatory data generation activities. * Ensure that other functions have support resources in place to generate regulatory data as needed. * Execute and track the aligned data generation and uses according to the overall regulatory strategy for consultations and submissions. * Consolidate Inari expertise to manage publications and information generation with regulatory implications. Represents Inari in technical regulatory discussions including agency visits. * Create and execute internal reviews as appropriate. * Represent Inari in advocacy activities focused on regulatory technical developments. * Work closely with other Regulatory functions (such as Regulatory compliance) and engage proactively in business-partnering with the Science, Product, and Commercial organizations. You Bring... * Minimum MS, preferably PhD in biological sciences or related disciplines with strong understanding and experience in molecular biology. * 5-7 years of work experience in biology related fields, preferably in agriculture. * Minimum 5 years work experience in generating regulatory data and data submission plans and support interactions with US regulatory agencies (USDA, EPA); additional experience with other international agencies preferred. * Strong business acumen, ability to understand strategies and business plan and co-develop integrated Regulatory data plans in service of timely delivery to support the business objectives. * Self-starter, pro-active communicator, and highly organized working style * 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.