Inari

About the role...

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 authorizations to support commercialization. This role manages submissions and ensures data availability is timely and according to agency requirements for gene-edited products with focus on China and other countries in Asia. This role is based in West Lafayette, IN; Cambridge, MA; or Ghent, Belgium 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 gene-edited technologies.
• Align and collaborate with Regulatory Science and R&D colleagues to ensure data is generated and available for submissions according to project plans.
• Execute the Regulatory project plans including agency consultation, managing agency submissions, and obtaining authorization according to plan for gene-edited products.
• Manage submissions and agency reviews with regulatory authorities both globally with focus on China and other APAC countries; represent Inari in interactions with regulatory agencies.
• Execute Regulatory Intelligence activities while overseeing evolution of data requirements and regulations framework at a global level.
• Monitor Regulatory competitive intelligence and information where available.
• Represent Inari in advocacy activities and share Inari position and knowledge to represent the technology.
• 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
• Mandarin language skills to prepare and review submission documents and agency correspondence
• At least 5 years work experience interacting with regulatory agencies, including but not limited to MARA (NBC)
• Strong business acumen, ability to understand strategies and business plan and co-develop integrated Regulatory plans in service of delivering the business objectives in a timely manner
• Self-starter, proactive 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

Inari is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Learn more about us:

About Inari: https://inari.com/about-us/

AgTech Breakthrough AgTech Company of the Year: https://www.globenewswire.com/news-release/2024/08/21/2933457/0/en/5th-Annual-AgTech-Breakthrough-Awards-Program-Showcases-Standout-Agriculture-and-Food-Technology-Innovation.html

Helping farmers feed the world: https://seedworld.com/faster-breeding-will-help-farmers-feed-the-world/

World Economic Forum Global Innovator: https://inari.com/news/inari-selected-for-world-economic-forums-global-innovators-community

Bloomberg: Inari AgTech Startup: https://www.bloomberg.com/news/articles/2021-05-12/agtech-startup-inari-nabs-new-funding-at-1-2-billion-valuation

Forbes: Gene editing with CRISPR: https://www.forbes.com/sites/lanabandoim/2021/05/21/gene-editing-seeds-with-crispr-is-transforming-agricultural-biotechnology/?sh=63d255e2163d

Inari at Databricks Data + AI Summit: https://www.youtube.com/watch?v=pJG-r3ob-n0

Inari at Re:Invent: https://youtu.be/FCSAwTiF450?t=2507

Job Applicant Privacy Notice: https://inari.com/wp-content/uploads/2024/09/Job-Applicant-Privacy-Notice.pdf

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.