Global Product Registration Manager

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 ofnaturally-occurringmicrobes modern gene editing and application technologies to provide nitrogen to crops. Weare dedicated to providingnew solutionsfor farmers to improve yield as they work to help feed the worlds growing population. Read/Hear more about Pivot Bio onForbesorPBS News Hour.

The Global Product Registration Manager will lead regulatory strategy and execution for the registration and commercialization of Pivot Bio products with a strong emphasis on United States federal and state regulatory requirements. This roleis responsible forensuringtimelyproduct approvalsmaintainingcompliance acrossjurisdictions and enabling market access through proactive engagement with regulatory authorities.

Essential Functions

• Develop and execute global regulatory strategies for Pivot Bio products with primary focus on U.S. regulatory frameworks including federal andstate-level registrations(e.g. soil amendmentbiostimulant and biofertilizer requirements).
• Lead the preparation submission and management of regulatory dossiers to U.S. agencies and individual state departments of agriculture ensuring alignment with varying state data requirements labeling standards and review timelines.
• Coordinate and manage state registration processes across all statesrequiredfor product commercial launch including renewals amendments and tonnage reporting
• Serve as the primary regulatory contact for U.S. state agencies building relationships and effectively responding to inquiries and data requests.
• Interpret evolving regulatory guidance related to gene-edited organisms microbial products and biotechnology translating requirements into actionable plans.
• Partner cross-functionally with regulatory science product development manufacturing quality and commercial teams tocreate productlabelsandcompile data packages supporting product safety efficacy and environmental impact.
• Partner with growth team to inform new partnershipstrategywith regards to potential regulatory pathways requirements 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 andstatelevelsidentifyingrisks and opportunities andadvisinginternal stakeholders on strategic implications.
• Ensure compliance with post-registration obligations including adverse event reporting tonnage reporting and label updates.
• Support global registrations outside the U.S. as needed ensuring consistency in regulatory strategy and documentation.
• Contribute to regulatory policy and advocacy efforts through engagement with industry groups and stakeholders.

Competencies

Knowledge & Application

• Demonstrated experiencewith U.S. federal and state registration processesparticularly for microbial products such as biopesticides biofertilizers orbiostimulants.
• Strong working knowledge of U.S. regulatory agencies and frameworks including familiarity with state-specific requirements and registration systems.
• Experience preparing andsubmittingregulatory dossiers including data related to product characterization toxicology environmental fate and efficacy.
• Understanding ofgene editing technologies (e.g. CRISPR) and their regulatory implications preferred.
• AIproficiency including the ability to responsiblyleverageAI-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.
• High attention to detail strong organizational skills and a proactivesolutions-oriented mindset.

Collaboration & Interaction

• Excellent communication technical writing and stakeholder engagement skills.
• Ability to work effectively in a cross-functional global environment and influence without direct authority.
• Collaborate cross-functionally with regulatory science product development manufacturing quality and commercial teams

Required Education & Experience

• Bachelorsdegree in Microbiology Molecular Biology Biotechnology Plant Sciences ora relatedscientific discipline.
• Minimum of8years of regulatory affairs experience in agricultural biologicalsbiotechnology or related industry.

Mustbe authorized towork in the United States

What We Offer:

• Incentive Bonus Plan
• Competitive package in a disruptive startup
• Stock options
• Health/Dental/Vision insurance with employer-paid premiums
• Life Short-Term and Long-Term Disability policies
• Employee Assistance Program with free referrals and discounts
• 401(k) plan 3% Match
• Commuter benefits
• Annual Training & Development support
• Flexible vacation policy with a generous holiday schedule
• Exciting opportunity to work with a talented and fun team

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