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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• Collects and disposes of all outdated controlled copies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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