Senior Manager, Regulatory Affairs, Crop Protection and Biotechnology

🕒 September 24

🇺🇸 United States – Remote

⏱ Part Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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knoell

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1996

💼 Consulting

🏥 Healthcare

🍽️ Food & Beverage

Consulting • Healthcare • Food & Beverage

knoell is an international regulatory and scientific consultancy that helps companies gain and maintain marketability for chemicals, crop protection, biocontrols, crop nutrition, biocides, medical devices, animal health products, food contact materials, cosmetics and related products. They provide end-to-end services including registration document preparation and submission, hazard/exposure/risk assessments, study management, quality management, and local representation across many countries using a 'glocal' approach combining global expertise with in-country regulatory knowledge.

📋 Description

• Direct preparation, implementation, and coordination of regulatory projects for new product registrations and lifecycle maintenance • Provide senior-level regulatory leadership for genetically engineered crops, genome editing, and other plant-breeding technologies • Develop and implement biotechnology regulatory strategies across the product lifecycle • Address USDA APHIS requirements under the Plant Protection Act and 7 CFR Part 340 • Address EPA requirements under FIFRA and the FD&C Act • Address FDA requirements and consultation processes • Provide senior-level regulatory leadership for agrochemicals under FIFRA • Perform comprehensive data gap analyses, draft waiver requests, and design testing strategies • Draft or review EPA product labels and related product communications, including seed tags, trait and stewardship statements, technology-use requirements, and federal labeling disclosures • Serve as the primary North American regulatory point of contact for the knoell team • Educate team members on regulatory pathways, risks, and opportunities • Support long-term client relationships • Mentor and provide technical guidance to regulatory specialists and managers • Participate in initial client inquiry calls and collaborate on proposals, quotes, and project budgets • Provide competitive intelligence and insights into emerging regulatory trends • Align North American strategies with international frameworks such as JMPR and the EU

🎯 Requirements

• Bachelor’s degree required in Biology, Chemistry, Toxicology, Natural Resources, or a related scientific discipline • Minimum of 8+ years of professional experience in the registration of genetically engineered crops and agrochemicals at the U.S. federal level • Proven track record registering products under EPA FIFRA for agrochemical crop protection and plant-incorporated protectants (PIPs) • Experience navigating USDA APHIS and FDA food and feed regulatory pathways for biotechnology-derived plants • Extensive experience in regulatory strategy, data requirements, and risk assessment frameworks • Exceptional written and verbal communication skills in English • Ability to translate complex regulatory concepts for diverse audiences • Experience with global crop protection and biotechnology regulations is preferred, particularly Canada, Latin America, and the EU • Experience with biologicals under FIFRA is beneficial • Understanding of U.S. state regulations is a plus • Professional working proficiency in German, Spanish, Portuguese, or Japanese would be an asset

🏖️ Benefits

• Flexible working policy • Remote-first work with flexibility to work from home, at headquarters in Mannheim, or at a local office based on your location • Part-time work options generally supported on request, subject to business requirements • Work-life balance support • English language courses • Personal, leadership, and technical development opportunities • Global employee referral program with rewards for referring talent • International team and collaboration with market leaders

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