Regulatory Manager

Job Description

The Regulatory Manager has overall responsibilities for NutriQuest regulatory requirements specifically international registration process, US approvals, sales material review, quality assurance, and product formulation management. This position will work closely with colleagues across multiple teams, as new products are advanced to the Regulatory organization, meets regulatory requirements, and ultimately enables commercialization of products.

Essential Functions

• Lead the product registration process to communicate registration plans, progress, and complete the prioritized registrations.
• Develop a project management model and best practices for regulatory oversight and interaction with NQ departments as needed to complete the registration process.
• Integration into the development teams to develop a domestic and international regulatory strategy for priority projects.
• Provide leadership to regulatory and quality assurance team members including goal setting, coaching and support, development plans, and identifying development opportunities for team members in alignment with their development plans and needs.
• Review and edit final sales materials to satisfy applicable regulatory requirements and geographic standards, while enabling sales and completing risk assessments.
• Act as the internal and external point of domestic and global contact for regulatory affairs regarding product registration projects for the company.
• Contribute to the optimal strategy and route to market for new products and feed additives developed by NutriQuest by working closely with the product development, quality, and commercial teams across the organization.
• Ensure compliance with US regulations for the company’s existing feed additives products.
• Work with external regulatory consultants to manage regulatory submissions including the preparation of dossiers for submission to the relevant regulatory bodies.
• Work closely with product development, quality, and commercial teams, keeping them up to date on any changes in regulations in the countries where products are already being commercialized.
• Support continuous improvement in global regulatory effectiveness through collaboration with key internal partners.

Qualifications

• Master’s Degree in, Animal Science, or related scientific discipline or 10+ years regulatory experience preferred
• Formal qualification/certification in regulatory affairs a plus
• Minimum five (5) years of practical experience working as a regulatory affairs supervisor with the animal feed, animal health, or similar industry
• Minimum three (3) years of compliance and regulatory requirements in the field of animal feed and health
• Global experience of animal feed regulations (FSMA, FDA, FAMI-QS, MAPA)
• Ability and desire to work in a fast-paced, dynamic environment

Competencies

• Customer Servant
• Excellent communication skills, both written and verbal
• Willingness to work in a team environment
• Problem Solving/Analysis
• Ethical Conduct

Travel Requirements

• Travel up to 25% and may include international travel

Direct Reports

• Quality Assurance Lead

Physical Demands

• Normal corrective vision range, ability to see color and distinguish letters, numbers, and symbols
• Ability to travel without physical assistance

NutriQuest

NutriQuest, headquartered in Mason City, Iowa, USA, delivers targeted breakthrough solutions to animal producers via nutritional and non-nutritional products, services, and technologies. Our industry-leading animal nutrition and production experts scrutinize products and technologies to ensure that all NutriQuest solutions meet or exceed our rigorous standards for efficacy, cost justification and practicality. At NutriQuest, we believe in ingenuity inspired by servitude and that our success comes from helping producers realize improved profitability through optimized technologies and efficient operation based on strategic production goals.