Principal Regulatory Affairs Assistant

5 days ago

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• 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.

Requirements

• 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)