Job Information
Actalent Regulatory Affairs Associate in Des Moines, Iowa
Description:
Oversee the Document Change Control System under the guidance of
the Regulatory Affairs Manager & 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.
• 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)
• 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• Collects and disposes of all outdated controlled copies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
• Other duties as assigned
Skills:
Regulatory affairs, Regulatory, Pharmaceutical, Document
Control, Regulatory compliance, USDA, FDA, Document Control System
Additional Skills & Qualifications:
• High school diploma or equivalent required; Associate degree
in a related field preferred.
• Previous experience in animal biologics, regulatory affairs,
or business management is desirable.
• Excellent customer service skills with the ability to listen,
analyze requests, and provide timely resolutions to customer issues.
• Effective verbal and written communication skills.
• Proficiency in organizing and tracking data and documents.
• Intermediate to advanced proficiency in Microsoft Office Suite
and electronic document control systems.
• Ability to read, write, and speak Spanish (preferred but not
required).
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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