Regulatory Affairs Specialist

DeLaval•Des Plaines, IL

6d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

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.
Bachelor's degree in Chemistry, Toxicology, Biochemistry, or a related field preferred.
Additional coursework in Animal Sciences is a plus.
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.

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.