Regulatory Affairs Specialist

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description

• Supports the preparation of documentation and submissions under EUCTR guidance.
• 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)

cta regulatory knowledge, regulatory submissions, health authority liaison, ctd/ectd formatting, clinical trial lifecycle understanding, attention to detail