Work schedule
standard office hours (40/wk)
environmental conditions
office
job description
join us as a regulatory affairs specialist for clinical trials – make an impact at the forefront of innovation
we have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to provide innovative solutions, including regulatory expertise and client interface, to offer strategic intelligence and guidance supporting product development from preclinical stages through registration and product optimization. As a regulatory affairs specialist, you'll provide strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ich regulatory and technical requirements. Additionally, you will act as a liaison with internal and external clients in the provision and marketing of these services.
What you’ll do
supports the preparation of documentation and submissions under 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. Assists with project budgeting/forecasting.
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 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.
Education and experience requirements:
bachelor's degree or equivalent and relevant formal academic / vocational qualification
previous experience that provides the knowledge, skills