Description
We are seeking a Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will serve as the primary contact with investigative sites during study maintenance and site startup activities. You will be responsible for collecting required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within agreed timelines.
Your main responsibilities will include:
- Developing awareness of regulatory legislation, guidance, and practice in assigned countries with senior staff support
- Assisting senior staff in compiling, preparing, submitting, and obtaining approval of submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements
- Liaising with internal and external vendors for Regulatory Authority submissions
- Reviewing final submission documents as applicable
- Organising communication related to submissions/outcomes within Fortrea
- Escalating study issues in a timely fashion
Additionally, you will perform country-specific tasks such as:
- Serving as primary contact for investigative sites and ensuring timely collection of required documents
- Collecting and tracking necessary documents, performing quality reviews, formatting, and compiling final documents for site activation and maintenance
- Ensuring all assigned maintenance and start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality, and applicable laws and guidelines
You will also support CTIS tasks, including uploading submission documentation to CTIS under supervision.
Qualifications:
- University/College degree (life science preferred), or certification in a related allied health profession from an accredited institution
- Minimum 0-2+ years of experience, or an equivalent combination of education and experience
Requirements:
- Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines
- Basic understanding of the clinical trial process
Work Environment:
- General Office Environment