Regulatory Operations Specialist

Who are we, and what do we do?

At Corteva Agriscience, you will help us grow what’s next. No matter your role, you will be part of a team that is building the future of agriculture – leading breakthroughs in the innovation and application of science and technology that will better the lives of people all over the world and fuel the progress of humankind.

Corteva Agriscience has an opportunity for a Regulatory Operations Specialist at our Global Headquarters in Indianapolis, In.

The Regulatory Operations Specialist (ROS) is a crucial member of several regulatory teams, each of which are 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.

Role

The ROS must work effectively on a high-level both internally and externally, with large, diverse networks, such as the EPA, State agencies and Corteva partners (e.g., Regulatory Sciences, various R&D functions, Commercial, Supply Chain, and Global Regulatory Leaders). ROS also serves as the subject matter expert or “Focal Point” for a variety of internal and external technical capabilities to support Federal and State needs. Creation of high-quality regulatory documents is a critical element of this role, and the ROS may be involved in various stages of this process including:

• The development, amendment and maintenance process for product labels and labeling in the U.S. that meet requirements of federal and state regulatory agencies while balancing the strategies and priorities of Corteva’s businesses. This includes coordinating and leading 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).
• Confidential statements of formula (CSFs) are required by the US EPA for all approved technical sources and registered formulated products. The ROS will oversee the draft 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 and is responsible for the regulatory submission process including preparing documents for the submission and tracking progress.
  
  

Additional Responsibilities Include

• Work, both independently and as a contributing member of multiple project teams, across internal businesses and functions (e.g., R&D, marketing, supply chain) to coordinate and prioritize numerous activities occurring simultaneously and adapt to shifting priorities and deadlines.
• 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.
  
  

What Skills You Need

• 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.
• 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
  
  

Benefits – How We’ll Support You

• 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
• Learn more about our total rewards package here - Corteva Benefits
• Check out life at Corteva! www.linkedin.com/company/corteva/life
  
  

Are you a good match? Apply today! We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team.

Corteva Agriscience is an equal opportunity employer. We are committed to embracing our differences to enrich lives, advance innovation, and boost company performance. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, military or veteran status, pregnancy related conditions (including pregnancy, childbirth, or related medical conditions), disability or any other protected status in accordance with federal, state, or local laws.