£50000 - £80000 per annum + benefits
11 months ago
Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Regulatory Submissions Technical Advisor to join our Clinical Operations team. This position plays a key role in the clinical trial management process. 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.
*Provide regulatory submissions strategic advice and guidance to the Regulatory Submissions Manager (RSM), project team, and Sponsor to ensure submissions compliance with appropriate regulations and requirements;
*Prepare and/or review core trial documents for compliance with relevant guidelines/regulations and for trial suitability;
*Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
*Independently interact with Sponsors, regulatory agencies and colleagues; and
*Present during bid defences, general capabilities meetings, and audits, as required.
*Bachelor's degree in Life Sciences - Master's/PhD preferred;
*Significant experience in clinical research, preferably with a CRO;
*Strong understanding of regulatory documentation, guidelines and legislation;
*Ability to review regulatory guidance and develop proactive solutions to regulatory issues and challenges;
*Experience in reviewing and/or writing core regulatory documents;
*Strong communication, critical thinking, and problem-solving skills;
*Ability to independently interact with national/regional regulatory agencies;
*Fluency in English.