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Collabera · 4 hours ago

Regulatory Affairs Associate

Florham Park, NJ

Contract

Onsite

Entry Level

$30/hr - $36/hr

2+ years exp

Collabera is seeking a Regulatory Affairs Associate I to support regulatory submission management activities for development, marketing, and post-marketing applications. The role involves managing submission projects, coordinating cross-functional teams, and ensuring compliance with regulatory standards.

ConsultingInformation ServicesInformation Technology

Hiring Manager

Gagandeep Singh

Responsibilities

Manage low to medium impact regulatory submission projects to ensure timely delivery of compliant and high-quality dossiers

Establish and maintain submission content planners and associated timelines in collaboration with cross-functional teams

Facilitate tactical submission team meetings and coordinate multiple concurrent submission activities

Provide regulatory submission support and guidance on established processes and standards to project teams

Coordinate submission publishing activities with external vendors and ensure required resources are available

Prepare content planners for publishing and support resolution of publishing-related issues

Facilitate preparation or procurement of submission deliverables such as cover letters and regulatory forms

Perform detailed quality reviews of published submissions to ensure compliance with regulatory standards and health authority guidance

Verify content accuracy including hyperlinks, bookmarks, tables of contents, and navigation elements

Contribute to continuous improvement of submission processes, standards, and internal documentation

Build and maintain effective working relationships with internal and external stakeholders

Manage assigned projects with oversight while providing regular progress updates to management

Qualification

Regulatory submission managementQuality review of submissionsDocument management toolsElectronic submission formatsCommunication skillsCollaboration skillsOrganizational skills