Manager to Senior Manager Regulatory and Scientific Affairs – Wilmington, Delaware / Remote
We are seeking a candidate with the following qualifications:
Ph.D. with 5-10 years or more of relevant experience; or M.S. with 8-15 years or more of relevant experience; or BS/BA with 10-20 years or more of relevant experience and knowledge of applicable laws and regulations under FIFRA, FQPA, and OSHA as applicable.
Nichino America’s Regulatory and Scientific Affairs Managers report to the department Vice-President and are responsible for hands on coordination and execution of all federal and state regulatory activities for their assigned crop protection active ingredients and products. They perform as dependable, integral members of a closely knit team while participating in substantial cross-department strategizing to:
- Address product registrations, re-registrations and data call-ins relevant to marketing strategies.
- Shorten registration time-lines, manage the EPA Risk Cup and build relationships with government agencies.
- Ensure compliance with all applicable federal and state laws, regulations, and EPA policies.
Key Essential Functions:
- Manages registrations for assigned NAI active ingredients and end-use products compliant with all applicable federal and state laws, regulations, and EPA policies.
- Develops and implements strategies to address generic or product specific Data Call-Ins or re-registrations which are relevant to NAI marketing strategies for the respective product.
- Plans, compiles, and submits registration applications to federal and state regulatory agencies and conduct follow up.
- Prepares Reduced-Risk rationales, minor use requests via IR-4, or other approach which impacts the anticipated review and approval schedule for the submission under EPA’s PRIA and priority systems.
- Facilitates meetings with federal or state scientific review personnel to negotiate and resolve issues which may arise during the review process.
- Develops strategies to shorten registration timelines, manage size of EPA dietary Risk Cup and partner with IR-4 group on minor crop submissions.
- Oversees risk assessments (dietary, aggregate exposure, ecological, environmental).
- Reviews product labels and Statement of Formulation for accuracy.
- Functions as study monitor or liaison between consultant and study monitor.
Physical Demands: In addition to performing work in an office environment, the successful candidate must be able to travel by motor vehicle, train, and aircraft.
Annual Overnight Travel: Approximately 15-25%. May include weekend travel days.
Job Classification: Full time, exempt
Nichino members enjoy an excellent health benefits package, competitive pay, paid vacation and sick leave.
Please CLICK HERE to submit your resume and to see Benefits-at-a-Glance.
Nichino America, Inc. is an Equal Opportunity Employer.