Regulatory Manager, Maintenance and CTA
Core
Manage regulatory activities for clinical trial applications across an assigned portfolio, ensuring alignment with regulatory requirements and internal processes.
Role type
Regulatory Manager, Clinical Trials
Builds
Clinical trial submissions and regulatory approvals
Domain
Pharmaceutical industry, Clinical Development
Required skills
Regulatory submission and approval processes, Health Authority query response, Product information management, Safety and efficacy data interpretation, Global cross-functional team collaboration
Preferred skills
Continuous improvement and automation initiatives
Technologies
Regulatory compliance and information management systems
Responsibilities
Lead high-quality clinical trial application submissions, Identify regulatory risks and gaps, Coordinate responses to Health Authority queries, Maintain accurate product information, Support preparation of documentation for Health Authority interactions, Contribute to continuous improvement initiatives
Seniority
Mid-level, hands-on IC