Senior Manager, Regulatory Affairs, Crop Protection and Biotechnology

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the preparation, execution, and management of regulatory projects for new product registrations and lifecycle upkeep.

• Provide expert regulatory guidance for genetically engineered crops, genome editing, and other plant-breeding technologies.

• Formulate and execute biotechnology regulatory strategies throughout the product lifecycle.

• Ensure compliance with USDA APHIS requirements under the Plant Protection Act and 7 CFR Part 340.

• Address EPA obligations under FIFRA and the FD&C Act.

• Manage FDA requirements and facilitate consultation processes.

• Offer senior-level regulatory oversight for agrochemicals under FIFRA.

• Conduct thorough data gap analyses, draft waiver requests, and develop testing strategies.

• Author or review EPA product labels and associated product communications, such as seed tags, trait and stewardship statements, technology-use requirements, and federal labeling disclosures.

• Act as the primary North American regulatory liaison for the knoell team.

• Train team members on regulatory pathways, risks, and opportunities.

• Foster long-term client relationships.

• Mentor and provide technical support to regulatory specialists and managers.

• Engage in initial client inquiry calls and collaborate on proposals, quotes, and project budgets.

• Deliver competitive intelligence and insights on emerging regulatory trends.

• Align North American strategies with international frameworks such as JMPR and the EU.

⛳️ Requirements

• A Bachelor’s degree in Biology, Chemistry, Toxicology, Natural Resources, or a related scientific field is required.

• At least 8+ years of professional experience in the registration of genetically engineered crops and agrochemicals at the U.S. federal level.

• Demonstrated success in registering products under EPA FIFRA for agrochemical crop protection and plant-incorporated protectants (PIPs).

• Proficient in 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.

• Outstanding written and verbal communication skills in English.

• Ability to convey complex regulatory concepts to varied audiences.

• Preferred experience with global crop protection and biotechnology regulations, especially in Canada, Latin America, and the EU.

• Beneficial experience with biologicals under FIFRA.

• Familiarity with U.S. state regulations is advantageous.

• Professional working proficiency in German, Spanish, Portuguese, or Japanese would be an asset.

🏝️ Benefits

• Flexible working policy.

• Remote-first work arrangement with the option to work from home, at headquarters in Mannheim, or in a local office based on your location.

• Part-time work options generally accommodated upon request, subject to business needs.

• Support for work-life balance.

• English language courses available.

• Opportunities for personal, leadership, and technical development.

• Global employee referral program with incentives for referring talent.

• An international team environment and collaboration with market leaders.