Pivot Bio

Global Product Registration Manager

Minnetonka, MN

Sponsorship not specifiedDetected 22 days ago

BioinformaticsCRISPRPharmacovigilanceResearchCommunicationCollaborationProblem SolvingWritingOrganizational Skills

About the role

Our first commercial product harnesses the power of naturally-occurring microbes, modern gene editing and application technologies to provide nitrogen to crops.
Read/Hear more about Pivot Bio on Forbes or PBS News Hour.
This role is responsible for ensuring timely product approvals, maintaining compliance across jurisdictions, and enabling market access through proactive engagement with regulatory authorities.

Coordinate and manage state registration processes across all states required for product commercial launch, including renewals, amendments, and tonnage reporting
Interpret evolving regulatory guidance related to gene-edited organisms, microbial products, and biotechnology, translating requirements into actionable plans.
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.
Contribute to regulatory policy and advocacy efforts through engagement with industry groups and stakeholders.
Demonstrated experience with U.S. federal and state registration processes, particularly for microbial products such as biopesticides, biofertilizers, or biostimulants.
Strong working knowledge of U.S. regulatory agencies and frameworks, including familiarity with state-specific requirements and registration systems.
Experience preparing and submitting regulatory dossiers, including data related to product characterization, toxicology, environmental fate, and efficacy.

This listing is sourced directly from Pivot Bio's careers page and normalized into a canonical job model.