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.
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.
Source: Job Diva – Job Listing