Description
The Regulatory Submissions Co-coordinator is accountable for Submissions management and delivery of regional and/or national regulatory dossiers to Worldwide Health Authorities.
On behalf of Worldwide Regulatory Strategy (WRS), lead and manage logistical and technical aspects associated with submission management, ensuring development and delivery of X-Regional, Regional and/or National regulatory dossiers (initial application, life cycle updates, compliance and maintenance) to Worldwide Health Authorities.
This role sits within a team working to tight, business-critical deadlines within a highly regulated environment. Primary focus is partnership with WRS remote and local colleagues (HQ and/or country based) to deliver for allocated region/countries, with responsibility to assign submission publishing tasks co-located and remote publishing locations through utilization of global tools.
Ideally, you will have had previous experience of working in the drug development process and be familiar with the publication of drug and trial information to regulatory bodies. Experience in working with Microsoft Office and familiar publishing tools is essential as are strong organisational skills, the ability to work within a team and to tight timescales and to work to strict process guidelines.
In accordance with our commitment to equality, we welcome applications from candidates of any age, disability, ethnicity, gender or religion for this role.