Associate ; Document Specialist; Regulatory Affairs Job Des Moines area,Iowa USA,Administrative/Clerical

Location 2538 SE 43RD ST,Des Moines, IA, ,United States
Employee Type FT Non-Exempt
Required Degree High school

Description

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Collects and disposes of all outdated controlled copies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
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

Requirements 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.

KNOWLEDGE, SKILLS AND ABILITIES:

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…