Principal Regulatory Affairs Assistant

at  Thermo Fisher Scientific

EDUCATION AND EXPERIENCE:

Excellent organizational and planning skills to effectively manage shifting priorities

• 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

Bachelor’s degree in pharmacy or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years). Prior experience with US or Canadian ethics committees that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years

• Supports the preparation of documentation and submissions of North American IRB and REB submissions
• 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.