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