Extensive regulatory experience with prescription medicines
Submission and registration of innovator medicines
Negotiations with tga and medsafe authorities
This senior role involves developing expert regulatory strategies and preparing complex submissions for the Australian and New Zealand markets
Job Summary
This senior role involves developing expert regulatory strategies and preparing complex submissions for the Australian and New Zealand markets.
The position requires extensive experience in the registration of innovator products and the ability to conduct regulatory due diligence for new in-licensing opportunities.
Candidates will collaborate cross-functionally with medical, safety, and commercial teams while managing relationships with regulatory authorities and international partners.
Matching Summary
This senior role involves developing expert regulatory strategies and preparing complex submissions for the Australian and New Zealand markets.
Skills & Requirements
Must-have
Extensive regulatory experience with prescription medicines
Submission and registration of innovator medicines
Negotiations with TGA and Medsafe authorities
Knowledge of Australian and New Zealand therapeutic goods legislation
Assessment of new in-licensing product opportunities
Nice-to-have
Excellent negotiation and persuasive writing skills
Ability to mentor less experienced team members
Experience leading contributions to consultation papers
Strong business acumen and solution focus
Collaborative team environment experience
Key Requirements
Tertiary qualification in biological science, allied medical discipline, or pharmacy
Extensive regulatory experience in Australia and New Zealand
Proven track record with TGA and Medsafe negotiations