Provides regulatory guidance throughout the clinical development life cycle
Compile, coordinate and review applications to Regulatory Authorities
Develops and/or reviews documents intended for submission to the Regulatory Authorities
Serve as representative of Global Regulatory Affairs at project team meetings
Works within a project team, and where necessary, leads project for the region or globally
Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
Maintenance of project plans, project trackers and regulatory intelligence tools
Assist in development of Regulatory Affairs Specialists and other operational area staff
Provide input into regulatory strategy and timeline development for new study opportunities
Participates in maintaining and executing on the corporate quality initiatives

Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
Computer literacy (MS Office/ Office 365)
Fluent in English
5 + years or more relevant regulatory affairs experience
Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones
Specialized knowledge of regulatory activities for at least one major region (EU, US)
Ability to understand clinical and pre-clinical study results
Knowledgeable of clinical trials methodology
Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
Availability for domestic and international travel including overnight stays

Regulatory Manager

About this role