Regulatory Operations Specialist

About the Role

The Regulatory Operations Specialist (ROS) is a crucial member of several regulatory teams, each comprised of a Regulatory Leader and/or other ROS(s), with primary responsibilities to assemble and deliver high quality regulatory documents (labels, confidential statements of formula) and submission packages (letters, forms, data, other documentation) on a diverse array of submission types for federal and state regulatory submissions for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and non-FIFRA products. Strong communication skills are required as the position requires a high level of interaction with the Environmental Protection Agency (EPA) and State regulatory personnel as well as cross-functional interactions within the company including commercial, supply chain, and other R&D functions. The role requires a key focus on organization, attention to detail, accuracy in data entry, and proofreading to ensure high-quality and timely regulatory actions aligned to registration strategies. Each regulatory team maintains responsibilities for multiple products, so the ability to multi-task, manage, and adapt to shifting priorities and timelines are additional core job expectations.

Key Responsibilities

• Work effectively both internally and externally with large, diverse networks such as the EPA, State agencies, and Corteva partners (Regulatory Sciences, R&D functions, Commercial, Supply Chain, Global Regulatory Leaders).
• Serve as the subject matter expert or "Focal Point" for a variety of internal and external technical capabilities to support Federal and State needs.
• Coordinate and lead labeling projects with key stakeholders including US regulatory leaders, marketing leaders, and biologists to draft, edit, and finalize regulatory text for labels used for registration and packaging under FIFRA Section 3, as well as labeling under Section 18, Section 24(c), and Section 2(ee).
• Oversee the draft Confidential Statements of Formula (CSF) and MOC process, coordinating with supply chain, manufacturing partners, US regulatory leaders, product chemistry manager, and formulation chemists to create and maintain CSFs according to current federal guidance.
• Provide oversight of the entire submission process from regulatory document creation, submission preparation, and execution.
• Develop and direct submission processes with small teams across portfolio to drive label creation and maintenance, address regulatory submission feedback, comply with federal and state electronic submission processes, and maintain internal best practices and process improvements.
• Lead the regulatory process in specific areas: submission documentation and process improvements, label creation, CSFs, renewals, payment processing, tracking and reporting requirements (ALSTAR, check and release, RAMS, RACE, FACTs), and maintain regulatory submission documents (8570 forms).
• Assemble letters, forms, data, and other documentation for regulatory submission to Federal and State government agencies.
• Lead communications and responses with state agencies to understand FIFRA and non-FIFRA submission and reporting requirements.
• Resolve state regulatory submission issues and document changes unique to each state.
• Oversee direct interactions and correspondence with state officials as needed.
• Plan, update, implement, track, and ensure accuracy of regulatory actions and registration strategies in a database.
• Respond appropriately using subject matter expertise to communications/actions received from states in functional mailboxes.
• Lead the product renewal process at both Federal and State agencies.
• Lead or actively participate in regulatory improvement and operational excellence projects.
• Create, update, and maintain EPA data matrices.
• Validate shipment of products within and to states ensuring compliance with registration requirements as part of the internal Check & Release process.
• Create workflows, dashboards, and reports to facilitate communication of the status of submissions and planning/strategy discussions.
• Provide internal process leadership and coordination associated with labels/labeling for a diverse portfolio of products.
• Maintain expert knowledge of label-related regulations and policies.
• Work both independently and as a contributing member of multiple project teams across internal businesses and functions (R&D, marketing, supply chain) to coordinate and prioritize numerous activities occurring simultaneously and adapt to shifting priorities and deadlines.

Qualifications

• Minimum of an associate degree with at least 5 years of relevant experience in an agricultural chemical industry or other highly regulated industry (bachelor's degree preferred).
• Background in agricultural chemical or biological product development or sales, legal, regulatory sciences, or environmental health is useful.
• Demonstrated experience in project management within and cross-functional to immediate team to implement complex processes, exercise discretion and independent judgement with federal and state regulatory agencies.
• Ability to multi-task and manage competing priorities essential due to time sensitive deadlines.
• Strong attention to detail and accuracy in proofreading and data entry to produce high quality submission packages.
• Strong written and verbal communication skills.
• High-level of interpersonal effectiveness and teamwork.
• Strong computer skills, including proficiency in Microsoft Office.
• Knowledge of and demonstrated experience with databases and web-based tools.

Benefits

• Numerous development opportunities offered to build your skills.
• Be part of a company with a higher purpose and contribute to making the world a better place.
• Health benefits for you and your family on your first day of employment.
• Four weeks of paid time off and two weeks of well-being pay per year, plus paid holidays.
• Excellent parental leave which includes a minimum of 16 weeks for mother and father.
• Future planning with our competitive retirement savings plan and tuition reimbursement program.