Senior Manager Regulatory Affairs
Core
Maximize client commercial success by ensuring regulatory compliance, licensing, and marketing authorization for pharmaceutical and medical device products in Australia and New Zealand.
Role type
Senior Manager Regulatory Affairs (Consulting)
Builds
Regulatory submissions and lifecycle maintenance for client products
Domain
Pharmaceutical industry, Healthcare regulatory affairs
Deliverable
client delivery
Required skills
Regulatory submission management, Lifecycle maintenance, Strategic regulatory solution development, Health authority liaison, Project management
Preferred skills
Stakeholder engagement, Independent work, Multitasking in fast-paced consulting
Technologies
Therapeutic Goods Administration (TGA), Medsafe
Responsibilities
Manage regulatory submissions and lifecycle maintenance for Australia and New Zealand; Ensure compliance with TGA & Medsafe regulations; Develop strategic regulatory solutions; Provide guidance on regulatory requirements; Liaise with health authorities
Seniority
Senior Manager, hands-on IC with strategic oversight
