Job Summary
A consulting firm is seeking a Remote Regulatory Operations Supervisor.
Individual must be able to fulfill the following responsibilities:
- Supervise or participate in software update implementation
- Participate in the interpretation and implementation of new health agency guidelines
- Manage or assist, in collaboration with Regulatory Operations team and sponsors
Qualifications for this position include:
- Bachelor's degree, or international equivalent from an accredited institution, in Science/Technology
- 3-4 years direct experience or 4-6 years experience in Regulatory Operations or a similar role
- In-depth experience in eCTD publishing tool(s) such as docuBridge, Global Submit and/or eCTDXpress
- Experience in web-based content and document management environments and file transfer sites
- Current knowledge of electronic document and submission requirements
