Regulatory Affairs Lead

About the role....

As the Regulatory Affairs Lead, you will be responsible for the creation, tracking, and execution of the overall regulatory plan to obtain needed authorizations for commercialization.  This role manages submissions, consultations, and ensures data availability is timely and according to quality requirements including Genetically Modified Organisms (GM post patent and Gene-edited GM), Gene-edited and Crop Protection products.   This role is based in West Lafayette, IN and reports to the VP of Regulatory.

As the Regulatory Affairs Lead, you will…

• Closely collaborate cross functionally, to ensure Regulatory Plans are in place to support Inari technologies 

• Create Regulatory Project Plans with timelines including launch considerations for cultivation and import of Inari Technologies including Gene-edited, Genetically Modified, and Crop Protection products (Gene-edited, GM and CP)

• Align and collaborate with Regulatory Science and R&D colleagues to ensure data is generated and available for submissions and consultations according to project plans

• Execute the Regulatory Project Plans including agency consultation, managing agency submissions, and obtaining authorization according to plan for Gene-edited, GM, and CP

• Manage submission and/or consultations with regulatory authorities both within the US and globally; represent Inari in interactions with regulatory agencies 

• Ensure variety registration when applicable and verify data needs and generation. Manage filing as needed in collaboration with legal 

• Obtain Field and Counter Season permits or regulatory clearances as appropriate to enable testing and seed increases

• Execute Regulatory Intelligence activities while overseeing evolution of data requirements and regulations framework at a global level

• Monitor Regulatory competitor activities and access to information where available.  Manage the internal access to such information

• Represent Inari in advocacy activities and share Inari position and knowledge to represent the technology including Regulatory and Stewardship frameworks along with public policy

• Monitor emerging issues and execute issue management at Inari.  Manage reporting obligations with Agencies. 

• 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 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 work experience supporting laboratory, greenhouse, and field operations 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 plan and co-develop integrated Regulatory plans in service of delivering the 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

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