Global Product Registration Manager

Responsibilities

• Develop and execute global regulatory strategies for Pivot Bio products, focusing on U.S. federal and state-level registrations
• Lead the preparation, submission, and management of regulatory dossiers to U.S. agencies and state departments of agriculture
• Coordinate state registration processes including renewals, amendments, and tonnage reporting
• Serve as the primary regulatory contact for U.S. state agencies
• Interpret evolving regulatory guidance related to gene-edited organisms and microbial products
• Partner cross-functionally with regulatory science, product development, manufacturing, quality, and commercial teams
• Monitor regulatory developments at federal and state levels to identify risks and opportunities
• Ensure compliance with post-registration obligations such as adverse event and tonnage reporting
• Support global registrations outside the U.S. as needed

Requirements

• Bachelor's degree in Microbiology, Molecular Biology, Biotechnology, Plant Sciences, or a related scientific discipline
• Minimum of 8 years of regulatory affairs experience in agricultural biologicals, biotechnology, or related industry
• Demonstrated experience with U.S. federal and state registration processes for microbial products
• Strong working knowledge of U.S. regulatory agencies and frameworks
• Experience preparing and submitting regulatory dossiers (toxicology, environmental fate, efficacy)
• Proficiency in leveraging AI-enabled tools for regulatory research and workflow efficiency
• Must be authorized to work in the United States

Preferred Qualifications

• Understanding of gene editing technologies (e.g., CRISPR) and their regulatory implications

Benefits

• Incentive Bonus Plan
• Stock options
• Health, Dental, and Vision insurance with employer-paid premiums
• Life, Short-Term, and Long-Term Disability policies
• 401(k) plan with 3% match
• Flexible vacation policy and generous holiday schedule
• Commuter benefits
• Annual Training & Development support

About the Company

Pivot Bio is pioneering game-changing advances in fertilizer technology by harnessing the power of naturally-occurring microbes and modern gene editing to provide nitrogen to crops.