Regulatory Operations Specialist

Corteva Agriscience • Indianapolis, IN

3d • Onsite

About The Position

Corteva Agriscience is seeking a Regulatory Operations Specialist (ROS) for its Global Headquarters in Indianapolis, Indiana. The ROS is a vital member of regulatory teams, responsible for assembling and delivering high-quality regulatory documents such as labels and confidential statements of formula, as well as submission packages for federal and state regulatory submissions for FIFRA and non-FIFRA products. This role requires strong communication skills for interaction with the Environmental Protection Agency (EPA), state regulatory personnel, and internal departments like commercial, supply chain, and R&D. A key focus is on organization, attention to detail, accuracy in data entry, and proofreading to ensure timely and high-quality regulatory actions aligned with registration strategies. The ability to multitask, manage, and adapt to shifting priorities and timelines is essential, as the ROS will manage multiple products simultaneously. The ROS will also serve as a subject matter expert for various internal and external technical capabilities supporting federal and state needs. This includes coordinating and leading labeling projects, drafting, editing, and finalizing regulatory text for labels under FIFRA Section 3, Section 18, Section 24(c), and Section 2(ee). The ROS will oversee the draft Confidential Statement of Formula (CSF) and MOC process, coordinating with supply chain, manufacturing, US regulatory leaders, product chemistry managers, and formulation chemists to create and maintain CSFs according to current federal guidance. The role involves overseeing the entire submission process, from document creation to execution, and developing submission processes to drive label creation, address feedback, comply with electronic submission processes, and implement process improvements. The ROS will lead regulatory processes for submission documentation, label creation, CSFs, renewals, payment processing, tracking, and reporting requirements. They will support US Regulatory Team Leaders in assembling submission packages, lead communications and responses with state agencies, resolve state regulatory submission issues, and oversee direct interactions with state officials. The ROS will plan, update, implement, track, and ensure accuracy of regulatory actions and registration strategies in a database, respond to communications from states, lead the product renewal process, and participate in regulatory improvement projects. Additionally, they will create and maintain EPA data matrices, validate product shipments for compliance, create workflows and dashboards for communication, and provide internal process leadership for labels/labeling, maintaining expert knowledge of label-related regulations and policies.

Requirements

• Minimum of an associate degree with at least 5 years of relevant experience in an agricultural chemical industry or other highly regulated industry.
• 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.
• The ability to multi-task and manage competing priorities are 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 are required.
• High-level of interpersonal effectiveness and teamwork.
• Strong computer skills, including proficiency in Microsoft Office are required.
• Knowledge of and demonstrated experience with databases and web-based tools.

Nice To Haves

• Bachelor’s degree preferred.
• Background in agricultural chemical or biological product development or sales, legal, regulatory sciences, or environmental health is useful.

Responsibilities

• 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.
• 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 Statement of Formula (CSF) and MOC process and coordinate with key stakeholders including supply chain and manufacturing partners, US regulatory leaders, product chemistry manager, and formulation chemists to create and maintain CSFs according to current federal guidance to meet compliance requirements.
• Provide oversight of the entire submission process from regulatory document creation, submission preparation, and execution.
• Develop and direct the submission processes, with small teams across portfolio, to drive label creation and maintenance, address regulatory submission feedback, comply with the federal and state electronic submission process, and maintain internal best practice and process improvements to facilitate efficiencies and use of centralized, submission and tracking databases.
• Lead the regulatory process, within specific areas of expertise and responsibilities to ensure consistency, efficiency, and regulatory compliance in the following areas: submission documentation and process improvements, label creation, CSFs, renewals, payment processing, tracking and reporting requirements (ALSTAR, check and release, RAMS, RACE, FACTs, update and maintain regulatory submission documents (8570 forms), etc.
• Support U.S. Regulatory Team Leaders in assembling letters, forms, data, and other documentation for regulatory submission to Federal and State government agencies to successfully address business objectives and regulatory requirements.
• Lead communications and responses with state agencies to understand FIFRA and non-FIFRA submission and reporting requirements to ensure high quality and timely submissions.
• Resolve state regulatory submission issues and documents changes unique to each state to ensure successful submissions.
• 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 to support US Regulatory and their interdependencies between Commercial Units for both Federal and State Submissions.
• Respond appropriately using Subject Matter Expertise to communications/actions received from the states in the functional mailboxes.
• Lead the product renewal process at both the 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree