Regulatory Affairs Manager
Core
Lead regulatory strategy and submissions for pharmaceutical products to ensure compliance and support commercialization in Australia and New Zealand.
Role type
Senior Regulatory Affairs Manager
Builds
Regulatory strategies, submissions, and compliance frameworks for pipeline and marketed pharmaceutical products
Domain
Pharmaceuticals / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, health authority interaction, submission management, lifecycle management, risk identification, cross-functional partnership, regulatory compliance monitoring, process improvement
Preferred skills
Advanced therapy medicinal products (ATMP) experience, US and EU regulatory process knowledge, market access and reimbursement submission experience
Technologies
GxP, CMC, pharmacovigilance systems
Responsibilities
Develop and execute regulatory strategies for product registration and lifecycle management; Lead regulatory submissions and health authority interactions; Provide strategic guidance on risks and opportunities for pipeline products; Partner with cross-functional teams on product launches and market access; Monitor regulatory environment changes and translate to business actions; Ensure ongoing compliance with GxP and quality requirements
Seniority
Senior, hands-on IC
