Regulatory Affairs Specialist

3 days ago


West Lafayette, Indiana, United States Inari Full time
About Inari

Inari is a pioneering company that harnesses the power of nature to drive innovation in the food system. Our mission is to transform the way we produce and consume food, making it more sustainable, productive, and equitable.

We are a diverse and inclusive team of experts from various fields, including agriculture, biotechnology, and software development. Our collaborative approach and commitment to excellence have enabled us to develop cutting-edge technologies that are revolutionizing the food industry.

The Role

We are seeking a highly skilled Regulatory Affairs Lead to join our team. As a key member of our regulatory team, you will be responsible for developing and executing our regulatory strategy to ensure the successful commercialization of our products.

Your primary focus will be on managing submissions, consultations, and data availability to meet quality requirements for genetically modified organisms (GMOs), gene-edited products, and crop protection products. You will work closely with our regulatory science and R&D teams to ensure that data is generated and available for submissions and consultations according to project plans.

Key Responsibilities
  • Develop and execute regulatory project plans with timelines, including launch considerations for cultivation and import of Inari technologies
  • Align and collaborate with regulatory science and R&D colleagues to ensure data is generated and available for submissions and consultations
  • Manage submissions and/or consultations with regulatory authorities, both within the US and globally, and represent Inari in interactions with regulatory agencies
  • Ensure variety registration when applicable and verify data needs and generation
  • Obtain field and counter-season permits or regulatory clearances as appropriate to enable testing and seed increases
  • Execute regulatory intelligence activities while overseeing the evolution of data requirements and regulations framework at a global level
  • Monitor regulatory competitor activities and access to information where available, and manage internal access to such information
  • Represent Inari in advocacy activities and share Inari's position and knowledge to represent the technology, including regulatory and stewardship frameworks, and public policy
  • Monitor emerging issues and execute issue management at Inari, and manage reporting obligations with agencies
Requirements
  • Solid experience in biological sciences, preferably agricultural sciences or molecular biology, or related disciplines; minimum BS degree, preferably MS or PhD degree
  • 5-7 years of work experience in agricultural biotechnology
  • Spanish language skills to prepare and review submission documents for counter-season applications
  • At least 5 years of work experience supporting laboratory, greenhouse, and field operations, and experience interacting with regulatory agencies, including but not limited to USDA, EPA, and FDA; experience with international agencies preferred
  • Strong business acumen, ability to understand strategies and business plans, and co-develop integrated regulatory plans in service of delivering business objectives timely
  • 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
What We Offer

We offer a dynamic and inclusive work environment, competitive compensation and benefits, and opportunities for professional growth and development. If you are a motivated and experienced regulatory affairs professional looking for a new challenge, we encourage you to apply for this exciting opportunity.



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