Overview
Reference Number: JO-2309-522960
Regulatory Submission Technical Advisor – Clinical
Rate: Negotiable
Job Type: Permanent
Location: Milan
Regulatory Submission Technical Advisor – Clinical Trials
Milan, Italy
An exciting opportunity to join a leading clinical research organisation that specialises in complex clinical trials for the UK, Europe, the US, and the rest of the world markets. You will be supporting and managing cutting-edge clinical trials in early- and late-phase including working closely with senior team members to ensure the right strategies are defined.
As a Regulatory Submission Technical Advisor you will be responsible for preparing, reviewing, and filing initial clinical trial applications to regulatory authorities and Ethics committees as well as ensuring submissions comply with applicable regulations and guidance documents. This will be a senior position in the organisation and will be accountable for defining strategies and working independently with sponsors and clients. You will also advise sponsors on changing regulations and compliance requirements. Including being well-informed about the new EU CTR regulation and CTIS portal.
Responsibilities:
- 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;
- Prepare and maintain Part I EU CTR submissions;
- 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.
Qualifications:
- Bachelor’s degree in Life Sciences – Master’s/PhD preferred;
- Significant experience in regional/global regulatory submissions;
- 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
This is an excellent opportunity to join a leading organisation that works on complex CTAs globally and will offer you plenty of career development opportunities The role also comes with a full benefits package and is a great role to develop more regulatory experience.
For more information please email your CV to lucy.kirkaldy@cpl.com
