Associate Director, Regulatory Labeling and Disclosures
Core
Leading global labeling activities and clinical trial disclosures for development and marketed gene therapy products.
Role type
Associate Director, Regulatory Labeling and Disclosures
Builds
US Full Prescribing Information, local labeling, Company Core Data Sheets (CCDS), Target Product Labeling (TPL), and clinical trial registration results.
Domain
Biopharmaceuticals / Gene Therapy / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global labeling strategy, Health Authority negotiations, clinical trial registration management, individual participant data (IPD) reporting, regulatory compliance, cross-functional team leadership, policy development, documentation management.
Preferred skills
Experience in regulatory labeling and/or disclosures, strong scientific education.
Technologies
Microsoft Office (Word, Excel, Outlook), regulatory systems, Clinicaltrials.gov, EU CTIS.
Responsibilities
Lead cross-functional teams to develop and maintain labeling documents; formulate global labeling strategy; manage clinical trial registration and results posting; partner with internal and external stakeholders; develop and execute company policies; ensure regulatory compliance and documentation integrity.
Seniority
Senior, hands-on IC with team leadership
