Regulatory Affairs Associate - secondment/fix-term contract
Core
Assists Regulatory Affairs Management in obtaining and maintaining licenses and applications, managing document tracking, and interfacing with Health Authority systems.
Role type
Regulatory Affairs Associate
Builds
Regulatory submissions and license applications for pharmaceutical products
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
Document management, Health Authority system navigation, Project management, Science background, English proficiency
Preferred skills
Biopharmaceutical industry experience, Knowledge of AZ submission processes, Regulatory/medical/technical experience
Technologies
Document management tools, HA Portals, EudraLink
Responsibilities
Uploading and tracking regulatory files, preparing and executing simple submissions, managing user fees and EudraCT numbers, ordering registration samples and legal documentation, acting as a superuser for non-drug projects, mentoring team members, contributing to process improvement
Seniority
Junior to Mid-level, hands-on IC