Edison-New Brunswick Metro Area, NJ
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