Director, Regulatory Affairs
Core
Lead regulatory strategy and execution for clinical-stage biopharmaceutical development programs, ensuring compliance with FDA and international frameworks.
Role type
Director, Regulatory Affairs (Senior IC)
Builds
Clinical development programs for novel protein-targeting therapeutics
Domain
Biopharmaceuticals / Oncology
Required skills
Regulatory strategy, FDA/international regulatory knowledge, IND/NDA/MAA submission management, cross-functional collaboration, risk assessment, quality systems (GCP/GLP)
Preferred skills
Oncology development experience
Technologies
Regulatory frameworks (FDA, EU, Japan, China)
Responsibilities
Develop and execute regulatory strategies, lead regulatory document submissions, maintain regulatory compliance, assess regulatory risks, support quality systems, collaborate with cross-functional teams
Seniority
Director, strategic leadership with hands-on execution