Regulatory Affairs Specialist

About This Role

This role involves supporting the preparation of documentation and submissions for regulatory compliance, particularly under EUCTR guidance. It suits a professional who can coordinate client deliverables and manage project plans while maintaining knowledge of regulatory guidelines.

Responsibilities

• Support the preparation of documentation and submissions under EUCTR guidance
• Coordinate and manage client deliverables supporting regulatory compliance
• Liaise with internal and external clients in the tracking and status update of project plans and overall support of projects
• Maintain knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines
• Evaluate client needs in relationship to overall project timelines, quality and delivery
• Engage 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
• Provide project specific services, documentation and coordination of projects and support reporting of same to management, internal and external clients
• Support preparation of bids and proposals; generate, track and analyze data for proposal, revisions, contract modifications and bid defenses

Requirements

• 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)

Important Details

• Schedule: Standard (Monday-Friday)