Senior Manager, Regulatory Affairs, Crop Protection and Biotechnology (part-time\remote)

knoell is a global service provider in regulatory registration, clinical development, and product development support. The company is seeking an experienced Senior Manager of Regulatory Affairs to advise clients on U.S. regulatory pathways for crop protection chemistry and agricultural biotechnology, lead registration and regulatory strategy projects, and mentor regulatory professionals.

Responsibilities:

• Direct the preparation, implementation, and coordination of regulatory projects for new product registrations and lifecycle maintenance across crop science portfolios for the U.S., as well as extended North America and Global Markets as your expertise supports
• Crop Biotechnology Regulatory Strategy: Provide senior-level regulatory leadership for plants developed using genetic engineering, genome editing, and other relevant plant-breeding technologies. Develop and implement regulatory strategies across the product lifecycle, including USDA APHIS requirements under the Plant Protection Act and 7 CFR Part 340, EPA requirements under FIFRA and the FD&C Act, and FDA requirements and consultation processes
• Crop Protection Regulatory Strategy: Provide senior-level regulatory leadership for agrochemicals. Develop and implement regulatory strategies across the product lifecycle, including Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements
• Data Strategy: In partnership with relevant internal technical experts, perform comprehensive data gap analyses, draft waiver requests, and design testing strategies to meet Federal requirements for crop protection and biotechnology
• Labeling Excellence: Draft or review crop protection and plant-incorporated protectant EPA product labels and, as applicable, product communications, including seed tags, trait and stewardship statements, technology-use requirements, and other federal labeling and disclosure requirements for crop protection and biotechnology
• Act as a primary point of contact for the knoell team for North America expertise, contributing to education of the team on regulatory pathways, risks, and opportunities while supporting long-term client relationships
• Mentor and provide technical guidance to regulatory specialists and managers, fostering a culture of continuous learning and skill development
• Proposals & Sales: Provide expertise alongside project managers in initial client inquiry calls, collaborate with internal sales teams on client proposals and quotes, and advise on budget needs based on project scope and complexity
• Regulatory Insight: Provide competitive intelligence and insights into emerging regulatory trends (e.g., new state-level regulations, Federal policy shifts)
• Global Collaboration: Work closely with global colleagues to align North American strategies with international frameworks (JMPR, EU, etc.)

Requirements:

• • Education: Bachelor's degree required in Biology, Chemistry, Toxicology, Natural Resources, or a related scientific discipline
• • Experience: Minimum of 8+ years of professional experience in the registration of genetically engineered crops and agrochemicals at the U.S. federal level
• • Regulatory Expertise and Portfolio Diversity: Proven track record of successfully registering products under EPA FIFRA for agrochemical crop protection and PIPs, as well as navigating USDA APHIS and FDA food and feed regulatory pathways for biotechnology-derived plants; with extensive experience in regulatory strategy, data requirements, and risk assessment frameworks
• • Communication: Exceptional written and verbal communication skills in English; able to translate complex regulatory concepts for diverse audiences
• (Advanced degree preferred.)
• (Additional global regulatory expertise preferred.)
• • Global Regulations: Experience with global crop protection and biotechnology regulations would add value, particularly those of Canada, Latin America, and the EU
• • Biologicals: Experience with the unique regulatory landscapes for biologicals under FIFRA would be of benefit
• • State-Level Knowledge: Understanding of U.S. state regulations is a plus
• • Languages: Professional working proficiency in in German, Spanish, Portuguese, or Japanese would be an asset due to our global client base