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Regulatory Compliance Analyst

2 months ago

West Lafayette, Indiana, United States Inari Full time

About Inari...

Inari is at the forefront of seed innovation, leveraging the intricate diversity of nature to drive groundbreaking advancements. Our cutting-edge technology platform employs predictive design and advanced multiplex gene editing to create transformative products. By adopting a nature-positive approach, we aim to unlock the full potential of seeds, revolutionizing the food system for a sustainable future.

Our success hinges on the collaboration of brilliant minds, generating innovative ideas and achieving exceptional results.

With a workforce of over 300, our research facilities are located in various regions, fostering a diverse team that brings unique perspectives to our operations. We combine seasoned industry experts with emerging talent from various fields, including academia and software, to create innovative solutions that address global food challenges while safeguarding our planet's resources.

About the Role...

As a Regulatory Affairs Specialist, you will play a crucial role in supporting the execution of our regulatory strategy to secure necessary approvals for commercialization. This position involves operational assistance for submissions and consultations, ensuring timely data availability that meets quality standards, particularly concerning Genetically Modified Organisms (GMOs) and Gene-edited products.

Key Responsibilities:

  • Collaborate cross-functionally to ensure effective tracking of Regulatory Plans that support Inari's technologies.
  • Assist in the development of Regulatory Project Plans, incorporating timelines and considerations for the cultivation and import of Inari's Gene-edited and GM products.
  • Work closely with Regulatory Science to guarantee that data is generated and available for submissions and consultations as per established plans.
  • Manage documentation for Regulatory Project Plans, including agency consultations and submissions, ensuring compliance with authorization requirements for Gene-edited and GM products.
  • Facilitate submissions and consultations with local and global regulatory authorities.
  • Support variety registration processes and verify data requirements, collaborating with legal for necessary filings.
  • Provide operational support for state registrations and submissions.
  • Assist in applications and consultations for Field and Counter Season permits to enable testing and seed increases.
  • Engage in Regulatory Intelligence activities, tracking the evolution of data requirements and regulatory frameworks globally.
  • Monitor competitor regulatory activities and manage internal access to relevant information.
  • Collaborate with other Regulatory functions and proactively engage with Science, Product, and Commercial teams.

Qualifications:

  • Solid background in biological sciences, preferably in agricultural sciences or related fields; a minimum of a BS degree is required, with an MS degree preferred.
  • 3-5 years of experience in agricultural or microbial biotechnology.
  • At least 3 years of experience supporting laboratory, greenhouse, and field operations.
  • Experience interacting with regulatory agencies, including USDA, EPA, and state agencies, is advantageous.
  • Self-motivated, proactive communicator with strong organizational skills.
  • Ability to work efficiently under tight deadlines while ensuring compliance.
  • A strong commitment to developing impactful solutions.
  • Adaptability, enthusiasm for new challenges, and a passion for continuous learning.
  • Creative and strategic thinker, willing to take calculated risks and learn from experiences.
  • A collaborative mindset, open to sharing and receiving diverse ideas and feedback.
  • Ability to work independently while aligning with company values and fostering a collaborative environment.
  • Effective communication skills to engage with a diverse range of individuals and audiences.

Note: Please ensure that your resume accurately reflects your work history, education, and relevant information, as discrepancies may affect your candidacy.