Project Associate Director-Regulatory Sciences

About the Department The IR-4 Project is a national Federal/State partnership research program to assist farmers of fruits, vegetables, nuts, herbs, ornamentals and other specialty crops by facilitating registration of safe and effective chemical and bio-based pest management products. The IR-4 Project is needed because the crop protection industry focuses their research efforts on major crops such as corn, soybean and cotton that provide the companies adequate return on their development investment.

Without IR-4, farmers of specialty crops would only have access to a few crop protection products to protect their crops. IR-4 Project Headquarters provides national leadership, coordination and regulatory compliance for the IR-4 Project research activities performed by approx. 125 scientists at over 20 public sector research farms and five analytical laboratories throughout the United States.

Essential Job Duties The Associate Director for Regulatory Sciences is part of the IR-4 Project’s national leadership team and part of the IR-4 Project National Headquarters at NC State. Reporting to the IR-4 Project Executive Director, this position is specifically responsible for IR-4’s flagship Food Crop Program, including research efforts to develop US Environmental Protection Agency (EPA) required Magnitude of the Residue (MOR) studies, regulatory submissions to enhance and expand crop groups/crop extrapolations, Integrated Solutions research, and international harmonization of pesticide regulatory schemes. As Associate Director, the incumbent is also involved in establishing and implementing national policies and procedures to ensure the efficient operations of the IR-4 Project. Specific responsibilities include, but are not limited to the following:

Supervise the activities and personnel of IR-4 Project Headquarters’ Food Program and regulatory support activities (50%): As leader of the Food Program team, actively manage/supervise advance degree scientists consisting of a Registration Manager, four Study Directors, and a Regulatory Support Manager to assure that stakeholder priorities research and regulatory activities are conducted, completed and results submitted to EPAwithin the given timelines. Accomplished by:

• Establish and maintain a team of competent and highly motivated regulatory scientists to perform required functions associated with MORstudies as outlined in the EPA Good Laboratory Practice Standards Regulations (Chapter 40, Code of Federal Regulations, Part 160) and various EPA Guidance Documents (e.g. 860s).
• Provide senior regulatory advice and guidance on protocol development, writing or submitting proposals to EPA’s CHEMSAC Committee.
• Establish an annual work plan for the team involving new assignments and expectations of reaching milestones of on-going assignments. Set priorities with the Registrations Manager for making submissions to EPAand Chemical companies.
• Trouble shoot various regulatory issues within the research and regulatory activities, including addressing GLP related issues, and other regulatory compliance issues from EPA.
• Work with the Registration Manager to maintain communications with partners (EPA, growers, and requestors, Chemical companies) on a timely basis to keep them informed of IR-4 progress.
• Provide oversight and guidance to the Regulatory Support Manager so that IR-4’s regulatory support assistance provided is consistent with mission, IR-4 capacity, and expertise. This includes assistance in the development and/or modification of new crop grouping models and extrapolation extensions, and assistance in helping pest management technology developed by public sector researchers get approval from EPA.
• Contribute to the development of new processes and procedures that utilizes available technology to improve IR-4 Project’s efficiencies, including expansion of eQA/eDoc systems, adaption of electronic notebook utilization at IR-4 field research centers, automation of the development of final study reports.
• Maintain and foster a positive relationship with EPA.
• Moderate the annual IR-4 National Research Planning Meeting including the development of pre-meeting materials (data requirements) and post meeting reporting.
• Working with the Executive Director, establish regular and frequent interaction with the Assistant Director for Research Planning and Product Performance Research and the Quality Assurance Manager to ensure that IR-4 management activates are consistent and harmonized.

Manage and coordinate IR-4 Project international activities (25%):

• Support USMCA (NAFTA) pesticide harmonization activities involving joint projects (residue studies, crop grouping, NAFTA grower database), joint reviews, and substantial similar registrations.
• Monitor annual JMPR work plan and provide IR-4s assistance including the provision of IR-4 data to support Codex MRLs for specialty crops into JMPR’s review cycle.
• Continue to develop and expand the IR-4 International program by preparing and providing data packages to international entities such as Canada, Codex, EU, etc.
• Participate in international meetings, such as NAFTA TWG, OECD, and Codex. Provide information to partners regarding the IR-4 international program, and provide ideas for new initiatives and strategies that would result in a more harmonized approach to globally recognized MRLs.
• Prepare crop group and minor use documents for the CCPR meetings and present the Crop Classification information on the floor of the CCPRmeeting.
• Represent IR-4 in discussions with USDA-Foreign Agriculture Service regarding pesticides and trade issues.
• Ensure all aspects of IR-4’s Technical Assistance for Specialty Crops (TASC) grants to solve trade barriers are completed, and appropriately reported.
• Attend other meetings as needed to develop international relationships, such as capacity building meetings with EPA and USDA–FAS, and other government meetings etc. Provide guidance to international partners on global residue studies, joint reviews, and other harmonization tools.
• Provide updates to IR-4 partners regarding the progress and development of the IR-4 International Program.
• Serve as with the liaison to the Minor Use Foundation.

Provide Administrative backup for the Executive Director of the IR-4 Project/other miscellaneous responsibilities (25%):

• Serve as Co-Principal investigator on IR-4 grants (NIFA, FAS etc).
• Review and provide input for all grant and budget documents to ensure they are in order.
• Serve as Acting Director, in the absence of the Executive Director, to proivde approvals for finacial payments and agreements, and sign off on submission documents for the EPA.
• Report on the activities and accomplishments of the Food Program at the IR-4 Project Management Committee Meeting.
• Develop year-end reporting information for the Food Program for inclusion in the IR-4 Annual Report.
• Attend meetings, provide updates at IR-4 meetings, and accompany the IR-4 HQ team members at chemical company technical meetings to ensure that the IR-4 database is up-to-date.
• Represent IR-4 in relevant work groups and committees associated with EPAregulatory affairs, including Crop Life America Registration Committee, EPAPesticide Program Dialogue Committee, Codex, etc.
• Manage IR-4 response to requests for technical information from US EPA on pesticide regulatory issues.
• Maintain accurate information on a timely basis to keep IR-4 and its partners informed of IR-4 progress.
• Continue to support the implementation of IR-4 Strategic Plan, especially in the areas of International and Biopesticde program enhancements.

Minimum Experience and Education

• PhD in the plant protection sciences (Entomology, Plant Pathology, and Weed Science), horticulture, or related area. All degrees must be received from appropriately accredited institutions.
• Multiple years of experience with managing research programs in the crop protection sciences.

Other Required Qualifications

• Must possess excellent organizational, leadership, interpersonal, decision-making, writing skills for a variety of audiences including for development purposes, and project management skills.

Preferred Qualifications

• At least 15 years of experience with managing research programs in the crop protection sciences.
• Experience working in regulatory sciences.
• Extensive knowledge of domestic and International specialty crop agriculture.

Required License(s) or Certification(s)

• Valid NC driver’s license or the ability to obtain with 60 days of start.