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Regulatory Affairs Manager (6961)

Company: NUFARM LIMITED
Location: West Sacramento
Posted on: June 6, 2021

Job Description:

Nuseed delivers value Beyond Yield through dedicated service, locally proven canola, carinata, sorghum and sunflower seed for farm customers and new plant-based solutions for end-use customers globally. This is core to our global commitment and what sets us apart. Over 250 Nuseed employees work across 11 global locations and two world-class Nuseed Innovation Centers. Established in Australia in 2006, Nuseed has grown to offer industry leading germplasm, advanced molecular capabilities, regional R&D and commercial teams in Australia, Europe, North and South America, and sales in more than 30 countries. Nuseed is a wholly owned subsidiary of Nufarm Limited.

Based in the West Sacrament, CA area, Nuseed offers an opportunity to thrive and develop your career while making a positive impact around the globe. Nuseed is a company with leading positions in canola, sunflower and sorghum crops encompassing breeding and seed production and commercialization. Reporting to the Global Regulatory Lead, the Regulatory Affairs Manager works closely with team members to develop and execute regulatory strategies for global food, feed, and dietary supplement approvals. Daily responsibilities include prepare and submit dossiers, interact regularly with FDA and other regulatory authorities, review regulatory documents and obtain required approvals to support product launch and business freedom to operate.

Reach your potential:

  • Map out regulatory pathway for product registrations in target aquafeed and dietary supplement markets.
  • Work with and across teams to guide and collect required data for smooth regulatory approvals, including desired claims for human consumption.
  • Prepare high-quality regulatory documents and reports to support global submissions and deregulation.
  • Address regulatory questions and resolve regulatory issues promptly by working closely with team members and local consultants. Proactively guide and communicate progress through regulatory processes.
  • Interact and maintain effective relationships with regulatory authorities, including the US FDA and other key stakeholders.
  • Lead assigned projects and manage contracted studies, including provide regulatory support and oversee material transfer between jurisdictions to meet regulatory and business needs
  • Keep abreast of the latest scientific and regulatory developments for aquafeed, nutraceutical and dietary supplements products. Proactively monitor and communicate US and global regulatory focused intelligence and policy trends to inform business and regulatory strategy
  • Work independently and creatively to foresee and address issues. Report on achievements, bottlenecks and proposed action for topics that will affect the regulatory strategy
  • Support regulatory compliance and stewardship efforts as needed.

Nuseed is looking for someone with 8 - 10 years direct experience in food/feed safety and biotech regulatory affairs. The right candidate will have a minimum of a Masters (Ph. D. preferred) degree in food sciences, nutrition and safety, oil chemistry, plant biotechnology or related disciplines. Experience in working with US FDA and other regulatory agencies in dietary supplement and food/feed ingredients fields is mandatory. Nuseed Nutritional focuses on developing and delivering highly innovative and sustainable omega-3 canola products. We are seeking an experienced Regulatory Affairs manager to drive and advance regulatory efforts for launching our Nutriterra and Aquaterra products in target markets. West Sacrament based is preferred but will consider remote work for the right candidate.

Do you want to be part of an organization committed to making the world a more sustainable place, through ground-breaking ag-innovation and R&D? We would love to hear from you.

We are an equal opportunity employer and we value diversity. All employment decisions are decided based on qualifications, merit and business needs. We are committed to building an inclusive environment for all Nuseed employees.

Keywords: NUFARM LIMITED, West Sacramento , Regulatory Affairs Manager (6961), Other , West Sacramento, California

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