Regulatory Affairs Associate

Katalyst HealthCares & Life Sciences

📍 Summit, New Jersey, United States 💼 Full-time 🕒 Posted July 02, 2026

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Job Description

 Job Description:
The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as very knowledgeable in their discipline expert and in regulatory affairs submission management.

 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 defi...
            

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Job Details

Location Summit, New Jersey
Job Type Full-time
Category Business Operations Specialists
Posted Date July 02, 2026
Application Deadline August 11, 2026