I’m working with a medium CRO who is looking for a submission specialist across Spain to do a regulatory role within their clinical research team.
The submission specialist will be responsible for ensuring all of the marketing materials are approved by the sponsors as well as ensuring the client is prepared for the trial start dates in order to recruit patients in a timely manner.
- Prepare, review and execute regulatory submissions to the Sponsor/CRO, IRB and other regulatory authorities
- Assist with the preparation of initial study documents
- Communicate with PI and Clinical Research Coordinator with regard to pertinent changes to protocol-specific requirements that may apply to the marketing materials
- Monitor portals for updates and ensure site staff are made aware immediately
- Prepare regulatory documents for initial submissions, communication with clients and IRBs, IRB submissions and approvals, and filing and maintenance of the study
- Assist with regulatory related tasks at monitoring and closeout visits
- Bachelor degree in life sciences or similar field
- Experience with submitting submissions including ethic and regulatory submissions
- Minimum 1 year of experience in a regulatory environment in Spain
- Excellent professional communication, punctual, and responsible
- A self-starter who takes initiative and likes to be hands-on
If you’re interested in taking that next stage within clinical research as a submission specialist then get in touch today so we can discuss:
?+44 1273 952187
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