Job Summary
A clinical research organization is seeking a Remote Associate Regulatory Submission Manager.
Core Responsibilities Include:
- Supervising the management of the cross-functional global submission teams
- Proactively escalating any timeline concerns, risks and issues that may delay/impact the project
- Ensuring the project team has sufficient awareness and knowledge of e-submission principles
Qualifications for this position include:
- Proven experience in developing and implementing novel technological solutions and processes
- Bachelors Degree is required
- Experience working within a Regulatory or Project Management environment
- Qualified project management experience
- Solid understanding of document management systems and concepts
- Familiar with the drug development process and evidence of working with Regulatory Agencies
