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Collabera · 1 day ago

Regulatory Affairs Associate

North Chicago, IL

Contract

Onsite

New Grad, Entry Level

$30/hr - $36/hr

Collabera is seeking a Regulatory Affairs Associate I to support regulatory activities for marketed products focusing on chemistry, manufacturing, and control documentation. This role involves authoring and managing regulatory submission content to ensure compliance with domestic and international requirements, while collaborating with cross-functional teams for timely regulatory filings.

ConsultingInformation ServicesInformation Technology

Hiring Manager

Gagandeep Singh

Responsibilities

Manage, compile, and author chemistry, manufacturing, and control sections for marketed product variations in support of regulatory submissions

Ensure common technical document content meets required structural, formatting, and regulatory standards

Coordinate cross-functional activities to support preparation, review, and submission of regulatory dossiers

Manage assigned projects to ensure accuracy, completeness, and on-time delivery of submissions and responses

Facilitate and lead project team and document review meetings as needed

Collaborate with regulatory project leads and functional partners to develop submission timelines and deliverables

Maintain awareness of evolving regulatory requirements and best practices related to regulatory documentation systems

Work independently while balancing multiple priorities and adapting to changes in project scope or business needs

Qualification

Regulatory affairs experienceChemistry documentationElectronic document managementCross-functional project supportAttention to detailWritten communicationVerbal communicationProject management