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.

SUMMARY

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 protectant (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.

YOUR ROLE

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 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.

Client & Team Collaboration:

• 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.).

YOUR PROFILE

Minimum Requirements:

• Education: Bachelor’s degree required in Biology, Chemistry, Toxicology, Natural Resources, or a related scientific discipline. (Advanced degree preferred.)
• Experience: Minimum of 8+ years of professional experience in the registration of genetically engineered crops and agrochemicals at the U.S. federal level. (Additional global regulatory expertise preferred.)
• 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.

Additional Skills and Preferences:

• 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.

WHAT WE OFFER

• Work in a dynamic family-owned business environment with an international team in which new ideas, creative approaches, and collaboration are valued.
• You will have the opportunity to work with market leaders in our industry.
• Development is core, and at knoell we offer various opportunities to support your personal, leadership and technical development, including English language courses to help you effectively communicate in our business language.
• knoell offers a flexible working policy and is a remote-first company, where you have the flexibility to work from home, at our headquarters in Mannheim or at one of our local offices based in your location. 
• Part-time work options are generally supported on request subject to meeting business requirements.
•  It is important to us that you have both a career and personal life – we celebrate the work-life balance of our colleagues.
• At knoell we have a global employee referral program as part of the recruitment process where you can actively participate and get rewarded for referring talent to knoell.

If you have any questions, feel free to reach out to us at application@knoell.com. If you're looking to join a global leader in regulatory and clinical services, where you can make a real impact and contribute to a team that values your contributions, then knoell is the place for you.

We look forward to receiving your application!