REGULATORY SUBMISSIONS MANAGER

Our client is an international CRO in the process of expansion, the position has home-based flexibility and is full time. The clinical operations activities of our client are growing rapidly, and they are currently seeking a Regulatory Submissions Manager to join the Clinical Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Requirements:
- Min 4 years experience in clinical research, preferably with CRO. (Experience may include CRA or Project management experience).
- Knowledge and experience of Clinical Trial Applications within Europe.
- Strong oral and written communication skills.
- Team-oriented approach and strong leadership skills.
- Fluency in English.

Main responsibilities:
- Efficiently manage and successfully execute all aspects of global start-up.
- Perform quality checks on submission documents and site essential documents.
- Prepare and approve informed consent forms.
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges.
- Present during bid defences, general capabilities meetings, and audits.

If this role sounds like something you would be interested in, please send your CV via this site.
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