Principal Associate, Regulatory Affairs
Core
Develop regulatory strategies and manage product registrations and maintenance for prescription medicines in Australia and New Zealand, supporting new product applications and in-licensing opportunities.
Role type
Principal Associate, Regulatory Affairs
Builds
Regulatory submissions, product lifecycle management, and in-licensing strategies for influenza vaccines and prescription medicines
Domain
Biotechnology / Pharmaceutical Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, submission planning and execution, change control evaluation, regulatory due diligence, SOP development, business agreement review, cross-functional collaboration, inspection and audit support
Preferred skills
Strategic and tactical thinking, hands-on operational approach, commercial awareness, project management, stakeholder communication
Technologies
Regulatory databases, internal SOP systems
Responsibilities
Develop regulatory strategies for new and existing products; Plan, prepare and submit high-quality applications in Australia/New Zealand; Evaluate change controls for regulatory impact; Support regulatory due diligence for new in-licensing opportunities; Review and update SOPs, guidelines, and work instructions; Support the review of business agreements including licensing and quality agreements; Collaborate cross-functionally to develop PI, CMI, and labelling materials; Manage regulatory aspects of medicine shortages; Provide regulatory support during inspections and audits
Seniority
Senior, hands-on IC
