Regulatory Affairs Specialist

DeLaval; Des Plaines (IL); Hybrid; USD 80,000 - 110,000; Full time

Benefits offered by this job

Competitive compensation

Year-end bonus

Paid vacation

401(k) with company match

Medical, Dental, Vision coverage

Work-life balance

And MORE!

Job summary

DeLaval is seeking a Regulatory Specialist in Des Plaines, IL to join the North America Regulatory Affairs team. This onsite/hybrid role focuses on preparing and maintaining product registrations for milk quality and animal health categories, coordinating with cross-functional teams to ensure compliance across the United States and Canada.

The candidate will review dossiers, labeling changes, and regulatory communications, bringing strong regulatory knowledge, attention to detail, and project

Qualifications

• Bachelor's degree in Chemistry, Toxicology, Biochemistry or related field.
• Three+ years of regulatory affairs experience in veterinary medicines or disinfectants.
• Experience with US FDA, EPA and Health Canada registrations.
• Knowledge of regulatory requirements for veterinary drugs, detergents, sanitizers and disinfectants.
• ISO/GLP regulatory experience is highly desirable.

Responsibilities

• Manage product registrations across North America (state and federal).
• Maintain, amend and renew existing registrations.
• Communicate with regulators and consultants regarding dossiers and inquiries.
• Review production docs for regulatory relevance to registrations.
• Prepare labeling changes and assess marketing materials for compliance.
• Ensure compliance with US and Canadian regulatory requirements.
• Collaborate with R&D, Product Management, Marketing and Manufacturing.
• Draft regulatory communications for internal and external stakeholders.
• Stay current on new regulations and implement regulatory strategies.

Skills

Regulatory affairs

Regulatory compliance

Project management

Attention to detail

Communication skills

MS Office

Adobe InDesign

GLP/GMP knowledge

Travel up to 10%

Education

Bachelor's degree in Chemistry/Toxicology/Biochemistry

Tools

Microsoft Office

Adobe InDesign

Job description

Job Description

Job Location: Des Plaines

Working Model: Hybrid

Regulatory Specialist

About The Job

Job Location: Des Plaines, IL

Title: Regulatory Specialist

Location: Onsite in Des Plaines, IL

Hours: 7:00 AM-5:00 PM, Monday-Friday

We are seeking a motivated and detail-oriented Regulatory Specialist to join our North America Regulatory Affairs team. This opportunity is ideal for a regulatory professional who is ready to take the next step in their career, build deep expertise in regulatory affairs, and grow long-term with a global industry leader.

The successful candidate will be a quick learner, confident in making recommendations, and comfortable collaborating with cross-functional teams to support business objectives and regulatory compliance across the United States and Canada.

In Support of Our Amazing Team, We Offer

• Competitive compensation
• Year-end bonus
• Paid vacation plus additional time off at the end of the year
• 401(k) with company match
• Medical, Dental, and Vision coverage
• Work-life balance
• And MORE!

About DeLaval

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 approximately 4,500 employees and operates in more than 100 markets. DeLaval, alongside Tetra Pak and Sidel, is part of the Tetra Laval Group.

At DeLaval, we prioritize our people and their safety. We pride ourselves on our culture of thinking and acting as One DeLaval. We also empower our people to Make Things Happen and encourage Setting Direction.

Learn more about DeLaval by visiting www.delaval.com/en-us/.

Basic Function

The Regulatory Specialist, reporting to the North America Regulatory Manager, is responsible for preparing, amending, and maintaining product registration dossiers for product categories within Milk Quality and Animal Health (MQAH). These categories include, but are not limited to, veterinary drugs for dairy cattle and sanitizers and disinfectants for dairy equipment.

This role works closely with Regulatory Affairs colleagues and cross-functional departments, including Product Management, Manufacturing, and Research & Development. The Regulatory Specialist will take on advanced regulatory responsibilities as assigned and play an important role in supporting regulatory compliance across the organization.

We are seeking an individual who is dedicated, motivated, confident in making decisions, and comfortable serving as a voice for DeLaval on regulatory matters.

Key Responsibilities

• Manage product registrations throughout North America, including the preparation and submission of state and federal registrations.
• Maintain existing product registrations, including amendments and renewals.
• Maintain regular communication with regulatory authorities and regulatory consultants regarding dossiers, documentation, and regulatory inquiries related to veterinary topical products and hard-surface detergents and disinfectants.
• Manage communications regarding data requirements for new and amended product registrations within DeLaval.
• Review and approve production documentation, including formulas, raw material monographs, and test methods, particularly as they relate to product registration dossiers.
• Review clinical trial protocols and final reports.
• Maintain product registrations to ensure compliance with United States and Canadian regulatory requirements.
• Prepare and coordinate product labeling changes.
• Evaluate label changes and marketing materials for regulatory compliance.
• Review and communicate potential health, safety, and environmental issues related to company products.
• Maintain FDA drug listings, registrations, and other applicable licenses.
• Research chemical compounds and Food Contact Notifications to support Research & Development projects.
• Develop and amend Safety Data Sheets as needed.
• Support cross-functional responsibilities with Quality Assurance related to product registrations and company compliance issues.
• Build and maintain strong working relationships with internal teams, including Research & Development, Product Management, Marketing, and Manufacturing.
• Collaborate with members of the Global Regulatory Affairs team to help resolve regulatory and quality issues.
• Author regulatory communications, including marketing and customer communications regarding regulatory impacts.
• Stay current on new and amended regulations, assess their impact on DeLaval, and communicate regulatory strategies for implementation to internal departments.
• Provide guidance regarding regulatory compliance requirements and potential risks associated with non-compliance.

Required Skills

• Ability to read and understand federal and state regulations, codes, and other technical documents.
• Strong verbal and written communication skills.
• Ability to manage multiple competing priorities and projects.
• Strong attention to detail.
• Ability to independently analyze and solve problems.Ability to manage projects and meet established timelines.
• Strong computer skills and proficiency in Microsoft Office.
• Experience with Adobe InDesign is a plus.
• Organic certification knowledge is a plus.
• Knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) is a plus.
• Ability to travel up to 10%.

Experience And Background

• Bachelor's degree in Chemistry, Toxicology, Biochemistry, or a related field preferred. Additional coursework in Animal Sciences is a plus.
• Technical background with three or more years of regulatory affairs experience in the veterinary medicinal or disinfectant industry.
• Experience working with the U.S. FDA, EPA, and Health Canada regarding new product registrations and label amendments in the United States and Canada.
• Knowledge of regulatory requirements for veterinary drugs, detergents, sanitizers, and disinfectants is preferred.
• Knowledge of dairy production is a plus.
• Knowledge of in-vitro testing and clinical trials would be beneficial.
• Experience working in an ISO or GLP regulatory environment is highly desired.

We are an equal opportunity employer.

Compliance & Regulatory Affairs