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 role is responsible for ensuring timely product approvals, maintaining compliance across jurisdictions, 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 and state-level registrations (e.g., soil amendment, biostimulant, 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 states required for 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 to create product labels and compile data packages supporting product safety, efficacy, and environmental impact.
- Partner with growth team to inform new partnership strategy with 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 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.
- 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 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.
- Understanding of gene editing technologies (e.g., 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.
- High attention to detail, strong organizational skills, and a proactive, solutions-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 - Bachelors 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.
Must be authorized to work 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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Hiring Compensation Range
$105,984-$132,480 USD
