Current Openings

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Regulatory Manager

Location: San Diego, CA
Position Type: Full-Time
Required Education: B.S., M.S. or equivalent
Area(s) of Expertise Desired: Regulatory expertise in field crops including gene editing and/or genetic modification. Industry or Regulatory Agency experience an asset.
Job Code: CO2287

Description:

Are you a Regulatory Science leader looking for a dynamic opportunity in the emerging field of plant gene editing? Do you have a drive for Innovation in Biotechnology and Commercialization of agricultural products?

As we prepare to bring innovation to North America field crops, Cibus has an immediate opening for a Regulatory Manager to help us to revolutionize plant breeding using our unique, patented gene editing technology. This position will obtain and maintain the freedom to develop, and place on the market, Cibus gene edited products in North America. The successful candidate will also partner with Cibus trait teams to provide regulatory and stewardship advice and support.

Cibus is a biotechnology company with advanced technologies to precisely target and direct a plant’s natural gene-editing processes. This approach accelerates natural plant breeding that has been a staple of farming for thousands of years and has resulted in a rapid, versatile, and low-cost way to produce sustainable industrial and agricultural products and improve human health by safely harnessing nature's own genetic diversity. Cibus is working to develop the first industrialized gene-editing platform through standardized, scaled production capability known as the Cibus Trait Machine.

The company has a worldwide presence, with subsidiaries in Europe and North America and a state-of-the-art research and development center in San Diego. Cibus has a pipeline of traits for canola and rice and is developing crop platforms and a pipeline of trait products in other major global crops including soybean, corn, and wheat. The broad applicability of Cibus’ technologies is highlighted by the company’s strain-advancement program, which develops sustainable products in microbial platforms for the food, flavor and fragrance, and personal care markets.

Role Responsibilities:

  • Develop and implement strategies to obtain the required regulatory approval to enable the planting and commercialization of Cibus gene edited products in USA and Canada in line with business team objectives.
  • Understand regulatory rules and guide development of internal protocols for Cibus to plant new gene edited plants in both North American target testing environments and contra-season nurseries.
  • Lead the development and implementation of North American regulatory plans in line with regional and international strategies.
  • Lead regulatory projects and participate in project teams to generate and maintain information required to ensure Cibus gene edited products can be developed and marketed in North America.
  • Lead and support the development, writing and submission of dossiers, pre-consultation meetings and other communications to regulatory authorities.
  • Manage the regulatory agency review process and regularly liaise with competent authorities to support and clarify Cibus gene editing approaches and obtain product approvals within defined timelines.
  • Monitor and provide updates to Cibus teams on the status of communications with regulatory authorities.
  • Serve on industry regulatory expert committees where applicable.
  • Provide Cibus Management with ongoing assessment of the Regulatory environment including competitive assessment.
  • Support regulatory activity outside North America as needed.
  • Support regulatory compliance and stewardship efforts as needed.

Requirements:

  • Bachelor’s Degree or higher in Agriculture, Biotechnology, Plant Biology, Plant Breeding, Molecular Biology or related disciplines.
  • Five years of work experience with regulated seed products and/or gene editing in a corporate, industry, or government organization.
  • In depth knowledge of U.S. and Canadian regulatory requirements and environment for gene edited products.
  • Knowledge of a broad range of scientific disciplines including plant molecular biology and general agricultural science.
  • Familiarity with plant breeding and agricultural production.
  • Ability to understand complex scientific, legal and business information to find the optimal solutions to regulatory challenges.
  • Experience and skills in the interpretation and communication (written and verbal) of technical and non-technical information to internal and external stakeholders.
  • Strong organizational and analytical skills with attention to detail.
  • Process-oriented mindset with a focus on results and a track record of success.
  • Ability to work under pressure while meeting the expectations and requirements of internal and external stakeholders.
  • Ability to work collaboratively in multicultural, cross-functional teams.
  • Ability to facilitate constructive discussions and resolution of complex issues to support critical and timely decision-making.
  • Strong written and verbal communications in English.
  • Fluent in MS office with strong digital skills.

Cibus provides an attractive compensation and benefits package that includes medical/ dental/ vision, flexible spending, 401(k) plan, vacation and sick leave. If you enjoy working as part of a team and want to participate in this exciting research, please e-mail resume to and put down job code: CO2287.