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SPECTRAFORCE · 2 hours ago

Associate – Regulatory Affairs Submission Management (Onsite)

Florham Park, NJ

Contract

Onsite

Entry Level

2+ years exp

SPECTRAFOR is a company focused on regulatory affairs, and they are seeking an Associate for their Regulatory Affairs Submission Management team. The role involves managing low to medium impact submission projects, coordinating with cross-functional teams, and ensuring compliance with regulatory standards.

ConsultingCRMInformation TechnologyLegal

Growth Opportunities

Hiring Manager

Naina Rathi

Responsibilities

Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency

Acts as RA Submissions support to project teams providing guidance and communication of established submission processes and standards. Provides input to project publishing timelines and deliverables

Participates in submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines. Anticipates obstacles and proposes solutions within the team

Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks

Facilitates the creation or procurement of submission content deliverables such as cover letters and forms

Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in low to moderately complex submissions. Facilitates team reviews

Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions

Contributes to the implementation of internal process and standards documents relating to publishing and publishing deliverables

Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software

Demonstrates ability to influence without direct authority. Builds and maintains positive relationships internally and externally

Position accountability/scope: oSupervision required. Receives project assignments from manager but has responsibility for managing own projects with oversight. Reviews project progress with manager on a regular basis with direction provided by manager. May assist with onboarding staff