Associate Regulatory Affairs Director
Core
Lead end-to-end planning, coordination, and execution of regulatory submissions for small and large molecules across global regions to ensure patient access to new medicines.
Role type
Senior IC regulatory affairs director (oncology)
Builds
Regulatory dossiers (NDA/MAA) and major lifecycle change submissions for oncology medicines
Domain
Biopharmaceuticals / Oncology
Required skills
Regulatory strategy, project management, cross-functional leadership, risk identification, health authority interaction, document management, process improvement
Preferred skills
First-wave marketing application management, complex deliverable management, internal business process knowledge
Technologies
OPAL, TMF systems
Responsibilities
Lead GRST & GRET sub-teams for major submissions; develop and execute submission delivery plans; identify regulatory risks and communicate mitigations; coordinate input from CROs and partners; provide coaching and mentoring within the RPM skill group; allocate resources and liaise with global project managers.
Seniority
Senior, hands-on IC with leadership responsibilities