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Regulatory Manager

Research and Development
Full time
Posted
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Nufarm Americas
Agriculture, forestry & fisheries
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Nuseed delivers VALUE BEYOND YIELD® through Canola, Carinata, Energy Cane, Sorghum and Sunflower seed for farm customers and new plant-based solutions for end-use customers globally. Our industry leading Beyond Yield Carinata and Omega-3 Canola products provide a truly sustainable platform recognizing the ever-evolving environmental challenges our world is facing. All of this is core to our global commitment and what sets us apart.

Over 350 Nuseed employees work across our global locations, including three world-class Nuseed Innovation Centers. Nuseed is a wholly owned subsidiary of Nufarm Limited (AUX: NUF).


Position Summary

  • Reporting to the Global Regulatory Lead, this position will focus on developing regulatory science strategy, provide guidance on study design and data collection, address technical questions to support regulatory approvals for biotech traits and products.

Objectives & Primary Responsibilities

  • Work with internal and external collaborators to guide and design regulatory studies, develop study protocols, collect and analyze required data, draft and review study reports, develop scientific rationale and response for biotech regulatory questions.
  • Manage regulatory science projects and CRO relationships. Serve as a study director for related projects and a liaison for external collaborations and project execution.
  • Review country specific data requirements, address technical questions and resolve regulatory issues promptly by working closely with team members and consultants.
  • Plan and coordinate test materials preparation and oversee material transfer with third parties to meet regulatory and business needs.
  • Work collaboratively and creatively to foresee, identify and address issues. Report on achievements, bottlenecks and proposed actions for topics that may affect regulatory strategy and Nuseed business.
  • Keep abreast of the latest scientific and regulatory developments for new genomic technologies, such as gene editing techniques and product development. Proactively monitor and communicate biotech and regulatory focused intelligence to inform regulatory strategy.
  • Lead regulatory scientific outreach and publication efforts. Make presentations to key stakeholders and at regulatory scientific conferences to advance safety reviews.

Position-Specific Skills & Experience Required

  • 8-10 years direct experience in Ag-biotech regulatory science and affairs. In-depth scientific knowledge and regulatory experience in biotech, food and feed safety, event detection, and new genomic technologies. Knowledge and experience in directing regulatory and/or GLP studies and obtaining global regulatory approvals are plus.
  • Master (Ph.D. preferred) degree in plant biotechnology, new genomic technologies, protein science and characterization, bioinformatics, oil chemistry, or related disciplines.
  • Technical savvy and strong analytical and problem-solving skills; capable to resolve technical complexity with end goal in mind.
  • Proven record as a strong self-starter and team player, responsible and comfortable to work independently and collaboratively.
  • Excellent interpretation, reasoning and writing skills. Proven track record of writing technical reports and regulatory documents. Ability to understand and clearly communicate complex technical issues.
  • Experienced in interacting with subject matter experts, regulatory and other stakeholders. Proven ability to act as an effective liaison with 3rd party collaborators.
  • Result driven and proven experiences in delivering results without close supervision.

Internal Stakeholders

  • Nuseed Regulatory and Stewardship team
  • Nuseed Nutritional team
  • Global R&D team

External Stakeholders

  • Contracted 3rd party research organizations and service providers
  • Regulatory agencies and scientific reviewers
  • Technology and business partners

The incumbent can expect to be allocated duties, not specifically mentioned in this document, but within the capacity, qualifications & experience normally expected from persons occupying positions at this classification.

The Company will make reasonable accommodations to individuals with known disabilities who are able to perform the essential functions of their jobs with or without such accommodations, unless doing so would impose an undue hardship on the Company’s operations. Individuals requiring accommodation should speak to the Company’s Human Resources Department concerning their needs.

Salary Range: $115,000 – $165,000 USD

Nuseed takes several factors into consideration when determining salary ranges. These factors include, but are not limited to, candidate experience, education, geographical location, and industry. Nuseed roles are incentive eligible and offer a robust benefit package that are not reflected in the noted salary range.