Senior Manager, Regulatory Affairs, Crop Protection and Biotechnology

United StatesRemotePart-timesenior

Legal & ComplianceRegulatory

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Quick Summary

Key Responsibilities

Lead the preparation, coordination, and implementation of regulatory registration projects and lifecycle maintenance activities across the United States, North America,

Technical Tools

Legal & ComplianceRegulatory

Join an international regulatory services team as a senior expert at the intersection of agricultural science, biotechnology, and regulatory strategy. In this part-time, remote role, you will guide clients through complex U.S. regulatory pathways for conventional crop protection products and biotechnology-derived plants. You will lead registration strategies, assess data requirements, and support products throughout their regulatory lifecycles, from initial planning to submission and approval. Working closely with technical specialists, project managers, and global colleagues, you will help deliver tailored solutions that meet evolving regulatory requirements. You will also mentor colleagues, strengthen client relationships, and contribute to business development through your technical expertise. This opportunity is ideal for an experienced regulatory professional seeking meaningful scientific challenges, international collaboration, and a flexible working arrangement.

As Senior Manager of Regulatory Affairs, you will provide strategic regulatory leadership across crop protection and agricultural biotechnology portfolios, ensuring that registration projects meet applicable federal requirements and client objectives. Your responsibilities will include:

Lead the preparation, coordination, and implementation of regulatory registration projects and lifecycle maintenance activities across the United States, North America, and other global markets as appropriate.
Develop regulatory strategies for genetically engineered, genome-edited, and other technology-derived plants, addressing USDA APHIS requirements under the Plant Protection Act and 7 CFR Part 340, EPA requirements under FIFRA and the FD&C Act, and relevant FDA requirements and consultation processes.
Lead regulatory strategy for conventional crop protection products, ensuring compliance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Conduct comprehensive data gap analyses in collaboration with technical experts, prepare waiver requests, and design testing strategies to meet federal regulatory requirements.
Draft and review EPA product labels for crop protection products and plant-incorporated protectants, including seed tags, trait and stewardship statements, technology-use requirements, and applicable product communications and disclosures.
Serve as a primary source of North American regulatory expertise, advising colleagues on regulatory pathways, risks, opportunities, and evolving requirements.
Mentor regulatory specialists and managers, providing technical guidance and supporting continuous professional development.
Collaborate with project managers and sales teams on client inquiries, proposals, quotations, and project budgets, taking into account scope and complexity.
Monitor regulatory developments, competitive intelligence, emerging state-level requirements, and changes in federal policy to inform client strategies.
Coordinate with international colleagues to align North American regulatory approaches with relevant global frameworks, including JMPR and European Union requirements.

Requirements

~2 min read

The ideal candidate combines extensive regulatory registration experience with strong scientific knowledge, strategic thinking, and the ability to communicate complex requirements clearly. You should be comfortable advising clients, mentoring colleagues, and coordinating projects across multidisciplinary and international teams. The key qualifications include:

A bachelor's degree in Biology, Chemistry, Toxicology, Natural Resources, or a related scientific discipline; an advanced degree is preferred.
At least eight years of professional experience in U.S. federal registration of genetically engineered crops and agrochemicals.
A proven track record of successfully registering crop protection products under EPA FIFRA and plant-incorporated protectants, alongside experience navigating USDA APHIS and FDA regulatory pathways for biotechnology-derived plants used in food and feed.
Extensive expertise in regulatory strategy, data requirements, and risk assessment frameworks relevant to crop protection and agricultural biotechnology.
Excellent written and verbal communication skills in English, with the ability to explain complex scientific and regulatory concepts to diverse audiences.
Strong analytical, organizational, and project coordination skills, with the ability to manage complex regulatory challenges and competing priorities.
The ability to collaborate effectively with clients, technical specialists, project managers, and international colleagues while providing senior-level guidance and mentorship.
Experience with international crop protection and biotechnology regulations, particularly in Canada, Latin America, and the European Union, is an advantage.
Knowledge of the regulatory frameworks for biological crop protection products under FIFRA is desirable.
Familiarity with U.S. state-level regulations is a plus.
Professional working proficiency in German, Spanish, Portuguese, or Japanese is an additional advantage.