Prin Reg Affairs Assistant

Work Schedule

Environmental Conditions

Job Description

Provides advanced administrative, contractual and financial support to the department, and supports reporting of such to upper management.

• 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 3+ years)

Knowledge, Skills and Abilities: 
 Excellent organizational and planning skills to effectively manage shifting priorities
 Strong understanding of contractal and proposal documents
 Capable of working effectively on a team and/or independently with minimal supervision
 Excellent electronic document production skills
 Excellent proficiency in several computer applications including Microsoft Office software
 Exceptional attention to detail and quality of documentation
 Outstanding interpersonal skills with the ability to interact with customers
 Excellent verbal and written communication skills
 Capable of multitasking and working under pressure 
 First-rate analytical, business and math skills