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 in-licensed products team at CSL Seqirus
Job Summary
This senior role involves developing expert regulatory strategies and preparing complex submissions for the in-licensed products team at CSL Seqirus.
The position requires extensive experience in registering innovator medicines and negotiating directly with the TGA and Medsafe regulatory authorities.
Candidates will collaborate cross-functionally with global partners and internal teams to introduce new therapies into the Australian and New Zealand markets.
Matching Summary
This senior role involves developing expert regulatory strategies and preparing complex submissions for the in-licensed products team at CSL Seqirus.
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
Cross-functional collaboration with medical and commercial teams
Nice-to-have
Experience mentoring less experienced team members
Strong business acumen and negotiation skills
Ability to work in a collaborative hybrid environment
Persuasive writing and problem-solving capabilities
Key Requirements
Tertiary qualification in biological science, allied medical discipline, or pharmacy
Extensive regulatory experience in Australia and New Zealand
Proven track record in submission and registration of innovator medicines