Regulatory Expert
Há 4 dias
Job Title: Regulatory Specialist
About the Role:This is a highly skilled position that requires strong knowledge of regulatory standards and guidelines. The successful candidate will be responsible for ensuring compliance with local regulations, interacting with regulatory authorities, and coordinating site start-up activities.
Key Responsibilities:- Maintain awareness of current regulatory standards related to submissions.
- Proactively interact with EC/IRB/Third body/Regulatory Authorities to provide guidance regarding requirements.
- Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable.
- Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval.
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
- Perform a review of final submission documents as applicable.
- Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards.
- Prevent and escalate study issues appropriately and in a timely fashion.
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations will be considered.
- Minimum of 3 years of experience in clinical development or start-up/regulatory process.
- Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.
- Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.
- Standard office environment with potential for remote work as applicable.
- Competitive salary and benefits package.
- Opportunities for career growth and professional development.
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