Senior Manager Regulatory Affairs
Core
Manage regulatory submissions, lifecycle maintenance, and licensing for pharmaceutical and medical device products in Australia and New Zealand.
Role type
Senior Manager Regulatory Affairs (Consulting)
Builds
Regulatory compliance, licensing, and marketing authorisation for client products
Domain
Pharmaceutical and healthcare industry
Deliverable
client delivery
Required skills
regulatory submissions management, lifecycle maintenance, strategic regulatory solution development, health authority liaison, project management, stakeholder engagement
Preferred skills
ability to work independently, fast-paced consulting environment adaptability, managing multiple projects simultaneously
Technologies
TGA, Medsafe
Responsibilities
Manage regulatory submissions and lifecycle maintenance for Australia and New Zealand; Ensure compliance with TGA & Medsafe regulations; Develop strategic regulatory solutions to support product approvals and expansions; Provide guidance on regulatory requirements for new and existing products; Liaise with health authorities and manage regulatory interactions
Seniority
Senior, hands-on IC with management responsibilities
