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Privy — Minnetonka, Minnesota
About Pivot Bio: Fueled by an innovative drive and a deep understanding of microbiology, genomics, crop nutrition and agriculture, Pivot Bio is pioneering game-changing advances in fertilizer technology. Our first commercial product harnesses the power of naturally-occurring microbes, modern gene editing and application technologies to provide nitrogen to crops. We are dedicated to providing new solutions for farmers to improve yield as they work to help feed the world’s growing population.
Read/Hear more about Pivot Bio on Forbes or PBS News Hour.
Requirements
This role is responsible for ensuring timely product approvals, maintaining compliance across jurisdictions, and enabling market access through proactive engagement with regulatory authorities. S.
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, labeling standards, and review timelines. S. state agencies, building relationships and effectively responding to inquiries and data requests.
into actionable plans. Partner cross-functionally with regulatory science, product development, manufacturing, quality, and commercial teams to create product labels and compile data packages supporting product safety, efficacy, and environmental impact.
, resources, and timelines. Forecast product registration resource needs based on commercial plans and build resources internally and/or externally to meet commercial timelines Monitor regulatory developments at both federal and state levels, identifying risks and opportunities, and advising internal stakeholders on strategic implications. Ensure compliance with post-registration obligations, including adverse event reporting, tonnage reporting, and label updates.
S. as needed, ensuring consistency in regulatory strategy and documentation. Contribute to regulatory policy and advocacy efforts through engagement with industry groups and stakeholders.
S. federal and state registration processes, particularly for microbial products such as biopesticides, biofertilizers, or biostimulants. S.
and registration systems. Experience preparing and submitting regulatory dossiers, including data related to product characterization, toxicology, environmental fate, and efficacy. , CRISPR) and their regulatory implications preferred.
AI proficiency, including the ability to responsibly leverage AI-enabled tools to improve regulatory research, dossier development, data synthesis, workflow efficiency, and cross-functional decision support. Complexity Problem Solving Proven ability to manage multiple complex projects and regulatory submissions simultaneously.