Specialist, Regulatory Affairs

Job Description For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence.

Because when it comes to animal health, no one sees it like we do. SUMMARY OF POSITION : This position is responsible for supporting internal tasks and filings that ensure regulatory filings of animal health products in pursuance of licensure and marketed animal health products are submitted in compliance with applicable USDA regulations and is within the Global Regulatory Affairs Bio team. This position is based in the US however closely working together with the GRA team located in the EU.

In this role, you participate in cross functional teams on maintenance of our products to provide support for filings made for marketed animal health products in compliance with applicable USDA regulations and regulations for relevant export regions. MAJOR ACTIVITIES AND RESPONSIBILITIES: This role provides project tracking, coordination, and administrative support for regulatory and compliance-related initiatives operating within a regulated environment.

This role is responsible for maintaining project schedules, monitoring key milestones and deadlines, and ensuring accurate documentation of project status and deliverables Develops and maintains profound knowledge of all relevant regulatory requirements   JOB DESCRIPTION: Maintain and manage spreadsheet-based trackers for project timelines, regulatory submissions, document outlines, and critical milestones.

Track multiple concurrent projects and deadlines, ensuring timely completion of activities and effective communication of schedule changes. Translate and interpret information from project management software into actionable reports, trackers, and status updates for stakeholders. Utilize Microsoft Teams, SharePoint, and other collaboration platforms to organize project documentation, facilitate communication, and support cross-functional teams.

Coordinate with internal stakeholders and external regulatory agencies to support submission activities, information requests, and regulatory commitments. Assist in maintaining compliance with applicable government regulations, policies, and procedures. Support document control and records management activities within a regulated environment. Adapt to shifting priorities, emerging business needs, and accelerated project timelines while maintaining accuracy and attention to detail.

REQUIRED EDUCATION & EXPERIENCE: Bachelor’s degree with a minimum of 3 years of regulatory experience. Experience working within a regulated industry such as pharmaceutical, animal health, biotechnology, medical device, food, or other government-regulated sectors. Familiarity with regulatory agencies and processes. Proficiency with Microsoft Office applications, particularly Excel, Teams, and SharePoint.

Experience using project management software and reporting tools. Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment. Excellent people, communication, leadership skills and well-developed cultural awareness for involvement with cross departmental teams. Excellent time and project management skills. Preferred: working knowledge of USDA requirements and regulations relating to manufacturing of biological vaccines but is not required.

Required Skills: Adaptability, Adaptability, Detail-Oriented, Document Controls, Document Management, Electronic Common Technical Document (eCTD), Employee Training Programs, Functional Management, Legal Compliance, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Progress Monitoring, Project Management Oversight, Project Management Tools, Project Pl