Extensive regulatory experience with prescription medicines in australia and new zealand
Submission and registration of innovator medicines involving clinical data
Knowledge of therapeutic goods legislation for australia and new zealand
This role involves developing expert regulatory strategies and preparing complex submissions for the Australian and New Zealand markets
Job Summary
This role involves developing expert regulatory strategies and preparing complex submissions for the Australian and New Zealand markets.
The position offers the opportunity to strengthen leadership experience while collaborating with highly skilled colleagues in a diverse in-licensing business.
Candidates will lead due diligence of new products and manage relationships with regulatory authorities, licensors, and internal stakeholders.
Matching Summary
This 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 in Australia and New Zealand
Submission and registration of innovator medicines involving clinical data
Knowledge of therapeutic goods legislation for Australia and New Zealand
Negotiations with TGA and Medsafe regulatory authorities
Cross-functional collaboration with medical, safety, and commercial teams
Nice-to-have
Experience mentoring less experienced team members
Business acumen for contract negotiations
Leadership experience in senior regulatory roles
Ability to work in a hybrid working environment
Strong problem-solving and persuasive writing skills
Key Requirements
Tertiary qualification in biological science, allied medical discipline, or pharmacy
Extensive experience in registration of innovator products in ANZ
Excellent knowledge of Australian and New Zealand therapeutic goods legislation