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Regulatory Manager

Location: 

Boise, ID, US, 83706-1211

The J.R. Simplot Company is a diverse, privately held organization, with roots firmly planted in agriculture and agriculture-related businesses. The J.R. Simplot Company is a true farm-to-table company with operations that touch every aspect of agriculture, including seed production, farming and ranching, plant sciences, fertilizer manufacturing, food processing, commercial product development, and distribution.

Summary

Applies developed-to-advanced subject matter knowledge to solve common and complex business issues within established guidelines, recommends appropriate alternatives, and may be considered a subject matter expert. Works on problems and projects of diverse complexity and scope, which may require in depth evaluation of multiple factors. Exercises independent judgment, within general to broadly defined policies and practices, to identify or determine the best method for accomplishing work and achieving objectives. May act as a team leader or project leader providing expertise or direction to team activities. May manage other employees as a primary job function. Validates information and facilitates team decision-making process. Ability to handle most unique situations. Develops cultural awareness for interactions with international stakeholders. May seek advice in order to make decisions on complex business issues. May provide guidance to other employees. May mentor colleagues. As an expert, provides direction and guidance to improve processes and establish policies. May represent the organization to regulatory authorities and other partners. Performs work assigned by others and assigns work to others. Technical leadership of assigned projects. Provides time / resource estimates for assigned projects. May develop solutions to complex regulatory problems.

Key Responsibilities

  • Write regulatory submissions and obtain approvals for biotech plant events (gene edited lines and traditional genetically engineered events) for multiple agencies/countries.
  • Perform statistical analyses of regulatory data for submissions.  Write up methods, archive data and analyses, and answer questions from regulators.
  • Leads report and submission development and review 
  • Maintains awareness and ensures protection of intellectual property 
  • Works effectively on multiple projects
  • Applies in-depth or broad technical knowledge to solutions across one or more technology areas
  • Applies appropriate technology to complex problem solving
  • Represents team to global regulators, industry groups, partners, and others
  • Demonstrates technical leadership, and exerts influence outside of immediate team 
  • Develops innovative team solutions to complex problems
  • Integrates technical expertise and business understanding to create optimal regulatory and QMS solutions for company and customers
  • Manages work completed by consultants and other vendors
  • May provide guidance and mentoring to other team members and company employees

Typical Education

  • Bachelor’s degree required, equivalent education and experience may be considered

Relevant Experience

  • 4-10 years’ experience writing regulatory submissions for biotech plant events
  • 4-10 years’ experience working with regulatory agencies in the United States and globally to advance submissions and obtain approvals
  • Proficiency in technical writing and editing in English. Ability to write technical biosafety information in a clear, concise, and grammatically correct way
  • Skilled in performing statistical analyses of plant biotech regulatory data, critical interpretation of analyses, writing up methods, and answering questions from regulators
  • Understanding of regulatory composition, expression, and agronomy studies
  • Understanding of genetic engineering, gene editing, and molecular biology
  • Attention to detail, organized, and ability to juggle multiple high-priority projects

Job Requisition ID: 10004

Travel Required: Less than 10%

Location(s): Irving St Building A R&D - Boise 

Country: United States

**The J.R. Simplot Company is proud to be an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, national origin, ancestry, age, sex, gender, gender identity, gender expression, genetic information, physical or mental disability, medical condition, sexual orientation, military or veteran status, marital status, or any other protected status.**

If you require technical assistance, please email us at careers.contact@simplot.com.