Regulatory Affairs Manager
Location: Research and Development
Job Type: Full time
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 400 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).
- Reporting to the Global Regulatory Lead, this position will focus on obtaining regulatory approvals and developing regulatory and nutritional science strategy for end-use applications. The role will also provide business and scientific support for Nuseed nutritional products.
Objectives & Primary Responsibilities
- Map out regulatory pathways for different end-use applications in target markets.
- Determine and design regulatory and clinical studies, identify collaborators and manage CROs to develop study protocols, collect and analyze required data, draft and review study reports.
- Prepare high quality regulatory dossiers and develop scientific rationale for regulatory submissions and approvals.
- Develop and comply with ingredient labeling and claims, etc.
- Interact and maintain effective relationships with regulatory authorities and other key stakeholders.
- Keep abreast of the latest scientific and regulatory developments for nutritional ingredients and applications. Perform literature reviews and build scientific evidence to support regulatory and business messaging.
- Provide project planning and management support for nutritional product development and applications.
- Support Nutritional business development. Collaborate with marketing to develop scientific communications.
- Develop whitepaper and technical sheets for products and key topics. Make presentations to key stakeholders as well as at industry or scientific conferences to support business needs.
Position-Specific Skills & Experience Required
- 10+ years direct experience in nutritional ingredient regulatory and science. In-depth scientific knowledge and regulatory experience in food and feed safety, dietary ingredient, and animal nutrition.
- Master (Ph.D. preferred) degree in nutritional science, food technologies, oil chemistry, plant biotechnology, or related disciplines.
- Knowledge and experience in directing regulatory and clinical studies. Experiences in working with US FDA and international regulatory agencies in dietary supplement and food/feed ingredient areas.
- Technical savvy and strong analytical and problem-solving skills; capable to resolve technical complexity with end goal in mind.
- Excellent communications, interpretation, reasoning and writing skills. Proven track record of writing technical reports and regulatory documents. Ability to translate complex technical issues into clear messages for end-users.
- Excellent project planning and management. Proven ability to act as an effective liaison with 3rd party collaborators.
- Strong self-starter and team player, responsible and comfortable to work independently and collaboratively.
- Result driven and proven experiences in delivering results without close supervision.
- Willingness to learn and go above and beyond.
- Nuseed Regulatory and Stewardship team
- Nuseed Nutritional team
- Nuseed regional business
- Contracted 3rd party research organizations and service providers
- Regulatory agencies and scientific experts
- Technology and business partners
- Industry groups
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.