Senior Director, Global Regulatory & Quality Affairs

Position Overview

About Pivot Bio: Fueled by innovation in microbiology, genomics, crop nutrition, and agriculture, Pivot Bio is pioneering game-changing advances in fertilizer technology. Our commercial product leverages naturally-occurring microbes, modern gene editing, and application technologies to provide nitrogen to crops. We are seeking a Senior Director, Global Regulatory and Quality Affairs to spearhead product registration, quality controls, and the development of high-value efficacy demonstration tools to support regulatory approvals and commercialization. This role is based at our center of excellence in St. Louis, MO and may require up to 20% travel.

Key Responsibilities

• Ensure products and processes meet the necessary safety, quality, and efficacy standards mandated by regulatory bodies.
• Build trust by maintaining high regulatory and quality standards, and engage in developing efficacy demonstration and communication strategies.
• Collaborate with manufacturing and R&D teams to enhance product reliability and showcase product value.
• Drive continuous improvement initiatives to adapt to evolving market expectations and maintain a competitive edge.
• Facilitate global market access by navigating international, federal, and state regulatory submission processes for quicker product approvals.
• Develop and execute strategic agency and partner engagements to support regulatory submissions.
• Monitor global policies and guidelines related to microbial biofertilizer products and proactively communicate changes to internal stakeholders.
• Gain a deep understanding of our science and commercialization plans to ensure accurate and timely registrations, meeting or exceeding product efficacy standards.
• Prepare and maintain routine registration progress reports.
• Be available for up to 20% travel for regulatory consultations, team, company, agency, and industry meetings.

Required Qualifications

• Ph.D., preferably in molecular biology, microbiology, or another agriculture-relevant field.
• 16+ years of relevant experience in scientific and regulatory affairs within the agricultural input industry; specific expertise with microbial biofertilizers is a plus.
• Familiarity with international agricultural regulations, with emphasis on LATAM regions considered an asset.
• Self-driven with the ability to manage multiple and evolving priorities.
• A strategic thinker with exceptional attention to detail.
• Strong interpersonal, written, and oral communication skills.
• Project management experience is viewed favorably.
• Must be authorized to work in the United States.

Benefits & Perks

• Compensation Range: $228,000 - $285,000 USD
• Remote positions and those not located in our Berkeley facility are compensated based on National Benchmark data.
• Opportunities for growth beyond the initial hiring range based on performance.