Associate I (Document Specialist) - Regulatory Affairs

JOB SUMMARY: The Regulatory Affairs Associate I will oversee the Document Change Control System under the guidance of the Regulatory Affairs Manager. Additionally, this role will offer general support to the Regulatory Affairs Department as required, assisting in applying regulatory requirements to ensure compliance with local, state, federal, and international authorities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Document Change Control: 80% of position responsibility

• Provides support with document formatting as required
• Assists and trains users on the Document Control System
• Tracks the progress of documents through the change system
• Verifies resolution of all change-related issues prior to document approval
• Distributes all newly revised documents
• Collects and disposes of all outdated controlled copies
• Updates and distributes Master Standard Operating Procedures Indices quarterly
• Scans and uploads documents to an electronic archive system

Regulatory Support: 15% of position responsibility

• Manages, tracks, and distributes correspondence with the USDA
• Supports dossier preparation tasks (e.g., photocopying, scanning, assembling binders)
• Assists in preparing Protocols and Reports (e.g., photocopying, scanning, compiling appendices)
• Aids in the preparation of International Registration documentation, including consularization and State Department Authentication
• Supports tasks related to Outlines of Production, Special Outlines, and Facilities Documents (e.g., photocopying, scanning, filing, distribution)
• Assists in revising controlled documents
• Facilitates Seed/Cell tracing activities (e.g., retrieving, scanning, uploading to an electronic archive system, filing)

Other duties as assigned: 5% of position responsibility

EDUCATION AND/OR EXPERIENCE:

• Minimum requirement is a High School diploma.
• Associate’s degree in science, business, or a related field is preferred.
• One year of experience in animal biologics, regulatory affairs, or business management.

• Strong customer service skills for both internal and external stakeholders, demonstrating the ability to listen, analyze requests and customer needs, and deliver timely and positive resolutions to issues.
• Effective verbal and written communication skills, always maintaining professionalism.
• Capability to provide training or assistance to individuals or small groups.
• Understanding of internal processes, procedures, and external regulatory requirements.
• Proficiency in organizing and tracking data and documents.
• Skilled in defining problems, collecting data, and drawing valid conclusions.
• Intermediate to advanced proficiency in Microsoft Office Suite, Internet Software, Email, and electronic document control systems.
• Ability to read, write, and speak Spanish (preferred but not required).
• Maintains confidentiality while appropriately disclosing information to key individuals.

The intellectual demands, physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

INTELLECTUAL DEMANDS:

• Proficient in reading and interpreting documents such as safety rules, operating instructions, and procedure manuals.
• Capable of writing routine reports and correspondence.
• Skilled in speaking effectively before small groups or individual employees.
• Able to perform basic mathematical operations including addition, subtraction, multiplication, and division using whole numbers, fractions, and decimals.
• Demonstrates the ability to apply common sense to carry out detailed instructions, whether written or oral.
• Capable of addressing issues involving multiple concrete variables in standardized situations.

PHYSICAL DEMANDS:

• Requires prolonged sitting, some bending, stooping, and stretching

WORK ENVIRONMENT:

• Typical office environment
• The noise level in the work environment is usually moderate

Why Join Diamond Animal Health

Join a company with over 60 years of expertise in advancing animal health solutions. At Diamond Animal Health, we combine deep industry knowledge with precision to deliver excellence in every stage of operations—from research and development to manufacturing and logistics. Our USDA-licensed and FDA-registered facilities, along with global distribution capabilities, position us as a trusted leader in animal health innovation. As part of a team that values collaboration and continuous improvement, you will contribute to a legacy of quality, safety, and innovation that impacts animals worldwide.

Our Benefits

We offer a comprehensive compensation and benefits package designed to support your financial, physical, and emotional well-being, including:

• Competitive pay and generous paid time off
• 9 paid holidays and up to 7 weeks of paid parental leave
• Health, dental, and vision plans with premiums as low as $0
• Employer-paid short-term disability, long-term disability, and life insurance
• 401(k) with company match
• Employee Assistance Program
• A collaborative, supportive culture with professional development and leadership growth opportunities

Ready to Make an Impact?

If you are passionate about improving animal health and want to be part of a team that values innovation, collaboration, and growth, apply today and help us shape the future of animal health!