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Job Description :
Responsible for providing support in Regulatory Operations filing multiple original INDs each year and managing multiple active INDs in Phase 1/2 clinical trials (US, Canada, EU and APAC). He/she will manage day to day regulatory operations to ensure all company regulatory submissions are on time, complete, and comply with applicable regulatory requirements, support completion of IND Annual Reports, IND Safety Reports and various types of amendments.
The position will also include aspects of eCTD publishing and formatting documents/reports per regulations for eCTDs and has hands-on experience using eCTD submission software.He/she will also assume responsibility for the tracking and filing of a large number of regulatory documents for archiving purposes.
The person will also contribute to company cross-functional project teams by translating regulatory requirements into practical, workable plans and providing strategic guidance on projects and submission document content. The right person will have the opportunity to play a dynamic leadership role in a small company environment including interaction with FDA and senior management from all functional areas of the company.
Essential Job Responsibilities:
Requirements
Below requirements are the minimum to be considered for the role.
Full Time
$167k-222k (estimate)
09/08/2024
09/21/2024
The following is the career advancement route for Director of Regulatory Affairs positions, which can be used as a reference in future career path planning. As a Director of Regulatory Affairs, it can be promoted into senior positions as a Top Regulatory Affairs Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Director of Regulatory Affairs. You can explore the career advancement for a Director of Regulatory Affairs below and select your interested title to get hiring information.