Main Purpose:

Plan, supervise, and prepare registration applications for field releases, seed import and movement, petitions for deregulation and consultations for food and feed safety. Organize and compile required information and submit to US regulatory agencies.  Compliance with all US and state legislation and regulations.

Principal tasks and accountabilities:

• Major task is to ensure regulatory compliance for laboratory, greenhouse, field trials, seed movement and deregulation by US government authorities (USDA and FDA) for assigned Nuseed products and uses in agreement with strategic business objectives.  Interact with technical experts to ensure the necessary scientific data; studies, documentation, interpretations and information are available in a timely manner.  In association with technical experts, business and others, formulates regulatory strategies to obtain registrations and defend products.  Influence regulatory agencies to obtain timely approval of pending petitions, consultations and actions.
• Maintain knowledge of current US government regulations, policies and contact with key regulatory authorities. Convey critical knowledge, especially that relating to assigned products, to Nuseed management, appropriate scientists, and others to alleviate or reduce regulatory impacts and costs.  Facilitate favorable regulatory outcomes through establishing appropriate internal and external meetings, advising appropriate data generation, and negotiation of requirements and risk mitigation.
• Lead the development of SOPs and other document/forms to ensure all working procedures are fully described and traceable. Ensure all Nuseed staff and contractors are fully trained and work in compliance with Federal and State authorities.
• Ensure that product claims are correct and current.  Review Nuseed advertising, label information, etc., for accuracy and regulatory compliance.
• Coordinate regulatory activities with NAFTA, global, Nufarm and other product business units to obtain consistent and harmonious regulatory approaches to maximize effectiveness and minimize costs for Nuseed.
• Represent Nuseed in industry trade association or work group activities as required.

Key relationships/communications:

This position reports to the Global Regulatory Lead.  In addition to the Global Regulatory Lead, this position’s primary interfaces are with other country Registration Managers, Project team members and USA Field staff.  This position also represents Nuseed as the contact person for USDA-APHIS-PPQ, USDA-APHIS-BRS and FDA.

Experience and qualifications:

• BA/BS in a science field, such as plant physiology, molecular biology, protein biochemistry, etc.
• Plus 2-5 years experience in the biotech crop industry, such as field trial applications/compliance experience or equivalent
• Project management experience
• Able to manage internal and external studies to meet regulatory requirements

Competencies:

• Strong written and oral communication skills, including negotiating skills
• Strategic and learning agility, coupled with integrity and trust
• Strong commitment to accuracy and attention to detail
• Able to motivate others with a drive for results
• Must be flexible and adept at accommodating shifting priorities
• Must be able to responsibly handle extremely confidential Company information
• Adept with computer skills: Microsoft Word, Excel, PowerPoint

Impact and influence:

Enables the sales, distribution of seed, seed products and allows free flow of Nuseed products into the U.S. from other Nuseed (and non-Nuseed suppliers) locations.  Regulatory approvals are critical for the success of Nuseed’s genetically modified trait business. Full compliance with all U.S. regulations and laws avoids potential fines for non-compliance or improper reporting. Doing this accurately and according to deadlines avoids shipments being held at ports of entry in the U.S. (which can disrupt shipment schedules, testing schedules and planting times at U.S. Nuseed).

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.

Please apply for this job on our website at: http://careers.us.nufarm.com/