GRA CMC Scientist
Core
Develop and execute global Chemistry, Manufacturing and Controls (CMC) regulatory strategies to support the development, registration, and lifecycle management of innovative biologic therapies.
Role type
Senior Regulatory Affairs Specialist (CMC)
Builds
Global regulatory dossiers and submissions for biologic medicinal products
Domain
Biotechnology / Pharmaceutical Regulatory Affairs
Required skills
CMC regulatory strategy, global regulatory frameworks, regulatory documentation preparation, cross-functional collaboration, risk assessment, change management, inspection readiness, project management
Preferred skills
Knowledge of Australian regulatory requirements, experience with marketing applications and clinical trial applications
Technologies
Regulatory submission platforms, quality management systems
Responsibilities
Develop and implement global CMC regulatory strategies for product development and lifecycle changes; Coordinate preparation and review of CMC regulatory documentation; Partner with technical teams to assess manufacturing and process changes for regulatory impact; Provide regulatory input into development projects and risk assessments; Interpret evolving global regulatory requirements; Support inspection readiness activities.
Seniority
Mid-Senior, hands-on IC