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 submissions to EC/IRB/Third body/Regulatory Authority are made within agreed timelines.
Responsibilities:
- Develop awareness of regulatory legislation, guidance, and practice in assigned countries with senior staff support
- Assist senior staff in compiling, preparing, submitting, and obtaining approval of submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements
- Liaise with internal and external vendors for Regulatory Authority submissions
- Review final submission documents as applicable
- Organise communication related to submissions/outcomes within Fortrea
- Escalate study issues in a timely fashion
- Perform other duties as assigned by management
In Country Specific Tasks (Global):
- Serve as primary contact for investigative sites and collect required documents in a timely manner
- Collect and track necessary documents, perform quality review, formatting, and compilation of final documents for site activation and maintenance
- Ensure 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
- Update study documents when there are changes in study personnel/study amendments
- Ensure high-quality documents are filed and systems are updated on an ongoing and timely basis
Clinical Trials Information System (CTIS) Tasks (Specific Centralized Role for EU):
- Upload submission documentation to CTIS under supervision as applicable
Qualifications:
- University/College degree (life science preferred), or certification in a related allied health profession from an accredited institution
- Relevant and equivalent experience in lieu of educational requirements may be considered
Experience:
- Minimum 0-2+ years of experience, or an equivalent combination of education and experience to successfully perform key responsibilities
- Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines
- Demonstrated basic understanding of the clinical trial process