Associate Director, Regulatory Labeling and Disclosures
Core
Leading global labeling activities and clinical trial disclosures for development and marketed products in the genetic medicine sector.
Role type
Senior individual contributor regulatory affairs lead
Builds
US Full Prescribing Information, local labeling documents, Company Core Data Sheets (CCDS), Target Product Labeling (TPL), and clinical trial registration results on Health Authority databases
Domain
Biotechnology / Genetic Medicine / Regulatory Affairs
Required skills
Regulatory labeling strategy, clinical trial disclosure management, Health Authority interaction, cross-functional team leadership, policy development, documentation management, evolving regulation knowledge
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 US Full Prescribing Information and local labeling; Contribute to global labeling strategy formulation; Ensure alignment between reference labeling and regional adaptations; Collaborate on package labeling artwork development; Support Health Authority interaction labeling strategy and submissions; Coordinate clinical trial registration and results posting; Manage individual participant data (IPD) report generation; Develop and execute company policies; Maintain regulatory compliance and documentation; Interact with Health Authorities to lead team engagements
Seniority
Director level, hands-on leadership