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

Join Us in Shaping the Future of Regulatory Services.

knoell is one of the leading global service providers in regulatory registration, clinical development, and product development support. As a family-owned business, we take pride in our commitment to the highest standards and believe that people are at the heart of our success. With our team of scientific and regulatory experts and an extensive network of partners, we ensure reliable solutions that address our clients' global business needs right from the start.

At knoell, we are guided by our core values of commitment, reliability, excellence and diversity. Are you someone who thrives in a collaborative environment? Do you take pride in delivering high-quality results and upholding excellence in everything you do? At knoell, we are passionate about embracing diverse perspectives, knowing that this fuels innovation and strengthens our impact. If you're ready to be part of a team that values these principles, we want to hear from you!

Think Globally. Act Locally.

knoell is seeking an experienced Senior Manager of Regulatory Affairs to join our North American team in a part-time capacity (16-20 total hours across 4 business days weekly). This position is designed for a seasoned professional who thrives at the intersection of science, regulation, and client strategy.

You will serve as a regulatory expert supporting clients navigating the U.S. regulatory pathways of conventional crop protection chemistry and agricultural biotechnology. This role involves collaborating closely with our local knoell USA team as well as our global network of experts to ensure seamless service delivery for our clients’ most critical registration and regulatory strategy projects and offers the opportunity to mentor other colleagues in developing regulatory expertise.

You will be the “go-to” expert for EPA FIFRA agrochemicals and plant-incorporated protect ant (PIP) registrations as well as relevant USDA and FDA requirements for genetically engineered crops/plants, providing support from early regulatory-pathway assessment and data-gap analysis through submission and final approval.

Strategic Registration & Regulatory Advice:

• 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 protect ant 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.

Client & Team

Collaboratio…