Regulatory Affairs Manager (6961)
Company: NUFARM LIMITED
Location: West Sacramento
Posted on: June 6, 2021
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
- 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
- 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
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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