Regulatory Affairs Specialist

REGULATORY AFFAIRS SPECIALIST, North America

Des Plaines, IL

DeLaval is a world leader in the dairy farming industry, providing integrated milking solutions designed to improve dairy farmers' production, animal welfare and overall quality of life. We support our customers in reducing their environmental footprint while improving food production, profitability and the well-being of the people and animals involved. We offer products, systems and services for all steps of milk production and animal comfort.

Our solutions are used by millions of dairy farmers around the globe every day.

DeLaval was founded more than 125 years ago in Sweden, when the visionary Gustaf de Laval patented the cream separator. Today, DeLaval has 4500 employees and operates in around 100 markets. DeLaval, alongside Tetra Pak and Sidel, is part of the Tetra Laval Group.

The Regulatory Specialist, reporting to the North America Regulatory Manager, is responsible for preparing, amending, and maintaining product registration dossiers for all product categories within Milk Quality and Animal Health (MQAH) including but not limited to veterinary drugs for dairy cattle and sanitizers/disinfectants for dairy equipment. We are seeking an individual that is dedicated, motivated, has the ability to make decisions and be the voice of DeLaval.

This role will work closely with the Regulatory colleagues with multiple departments, including Product Management, Manufacturing, and Research & Development, and take on advanced Regulatory responsibilities as assigned. We are looking for someone who is a quick learner and is confident to make recommendations/suggestions on regulatory topics. DeLaval’s opportunity is ideal for a Regulatory professional who is seeking the next level in their career.

• Responsible for product registrations for North America including state and federal preparation submissions and maintenance of existing registrations, including amendments. Responsible for renewal of Federal and State product registrations.
• Maintain regular contacts with Regulatory Authorities and regulatory consultants for the follow-up of dossiers, documentation or queries, related to veterinary topical products and hard surfaces detergents/disinfectants.
• Manage communications on needed data requirements for new and amended registrations within Delaval.
• Review/approve production documentation (i.e. formula, raw material monographs, test methods, etc.) particularly pertaining to product registration dossiers.
• Review clinical trial protocols and review final reports.
• Maintain all product registrations for compliance to US and Canada requirements.
• Prepare and design labeling changes for products.
• Evaluate label changes and marketing materials for regulatory compliance.
• Review and communicate any health, safety and environmental potential issues with company products.
• Determine, maintain FDA drug listings, registrations and other licenses.
• Research chemical compounds and Food Contact Notifications for R&D project development.
• Develop/amend Safety Data Sheets.
• May have cross-functional responsibilities with Quality Assurance with respect to product registrations and company compliance issues.
• Maintain good working relationships with various internal groups such as R&D, Product Management, Marketing, and Manufacturing.
• Work with other members of the Global Regulatory Affairs team to help solve global regulatory and quality issues.
• Author regulatory marketing and press releases to customers regarding regulatory impacts.
• Keep up with new and amended regulations. Assess their impacts to DeLaval and communicate regulatory strategies for implementation to internal departments; provide guidance on risks of non-compliance.

• Ability to read and understand federal/state codes and other technical writings.
• Strong communication skills both in-person and in writing.
• Ability to handle multiple, competing priorities and projects.
• Detail oriented.
• Ability to independently solve problems.
• Able to manage projects and keep within timeline.
• Computer literate and strong experience with MS Office required. Experience with Adobe InDesign a plus.
• Organic certification knowledge a plus.
• GLP and GMP knowledge a plus.
• Ability to travel 10%.

• B.S. degree in Chemistry, Toxicology, Biochemistry with additional course work in Animal Sciences preferred.
• Technical background required with 3+ years of regulatory affairs experience in the veterinary medicinal or disinfectant business.
• Experience with US FDA, EPA, and Health Canada regarding new product registrations and label amendments in US and Canada.
• Knowledge of regulatory requirements for veterinary drugs, detergents, sanitizers, and disinfectants desired.
• Knowledge of dairy production is a plus and knowledge of in-vitro testing and clinical trials would be a benefit.
• Experience in an ISO or GLP regulatory environment would be highly desired.

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