Regulatory Affairs Specialist
Há 18 horas
Job Overview:
The primary contact with investigative sites during start-up activities and maintenance involves collecting required investigator and essential documents to ensure timely submission of EC/IRB/Third Body and Regulatory Authority applications. This role requires interaction with regulatory authorities to provide guidance on requirements and maintain awareness of current standards.
Key Responsibilities include:
- Maintain knowledge of regulatory legislation, guidance, and practice in assigned countries.
- Coordinate collection and organization of data and information required by regulatory bodies, including preparation of study documentation.
- Compile and prepare routine submissions filed to IRB/IEC/Third Body and Regulatory Authorities, liaising with them as applicable.
- Liaise with internal and external vendors for regulatory authority submissions.
- Perform review of final submission documents.
- Ensure assigned start-up and maintenance activities are on track, meeting client expectations and regulatory requirements.
Required Skills and Qualifications:
- University degree (life science preferred) or certification in a related allied health profession, along with 2 years' work experience in clinical research.
- Strong working knowledge of ICH guidelines and RA, IRB/IEC regulations.
- Familiarity with investigator start-up documents and contract/budget negotiation process.
- Previous interaction with operational project teams and investigative sites.
Benefits:
- General Office Environment.
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