The Reg Affairs Specialist supports regulatory compliance by managing project deliverables, preparing documentation, liaising with clients, and ensuring adherence to guidelines.
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
- Supports the preparation of documentation and submissions under EUCTR guidance.
- Having good knowledge of RIMS documents managements.
- Coordinates and manages client deliverables supporting regulatory compliance.
- Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects.
- Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.
- Evaluates client needs in relationship to overall project timelines, quality and delivery.
- Engages with other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed
- Provides project specific services, documentation and coordination of projects and supports reporting of same to management, internal and external clients.
- Supports preparation of bids and proposals; generates, tracks and analyses data for proposal, revisions, contract modifications and bid defenses.
Education and Experience:
Bachelor's or Master’s degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
Top Skills
Eu Clinical Trials Regulation
Rims Documents Management
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