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Scientific. Clinical. Software Engineering

Regulatory Coordinator

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -042019-24623 Region: Edison-New Brunswick Metro Area

Job Description

The Regulatory Coordinator is responsible for providing operational regulatory and compliance support on development projects/major line extensions through development, registration, and approval including post approval commitments.

Major Accountabilities (Describe the main results of the role to be achieved)
  • Manage and prepare Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment , and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations
  • Contribute to Module #1 documents including FDA forms and cover letters for maintenance submissions with management oversight
  • Conduct monthly reconciliation to ensure timely submissions are in accordance with FDA regulations as well as meeting all requirements for submission-related activities
  • Support US regulatory compliance activities, including timely review and updates to product specific information as provided by program team representative into a compliance database (DRAGON), when applicable
  • Manage the user fee registration requests
  • Manage and execute drug shipment ticket review process (US)
  • In addition to regulatory manager, provide guidance to clinical functions on regulatory compliance activities, such as requirements for TOOs, VDRs, drug shipment etc.
  • Assist regulatory managers to support compilation and release of submissions to regulatory agencies as well as submission-related activities for regulatory responses to health authorities
  • Minimum of 2 years pharmaceutical experience desired
  • Prior publishing/Regulatory Operations experience desired.
  • Good communication and negotiation skills.
  • Proactive personality.
  • Fast and flexible, focused on timely delivery and stretch targets
  • Ability to plan and prioritize workload
  • Ability to work in a matrixed environment.
  • Ability to build effective relationships across teams/projects.
  • Bachelors degree preferred
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