Associate Director, Regulatory Affairs

CSL Seqirus

Melbourne, Australia
Hybrid
Extensive regulatory experience with prescription medicines in australia and new zealand
Submission and registration of innovator medicines or major variations involving clinical data
Excellent working knowledge of therapeutic goods legislation and guidelines for australia and new zealand
This senior position involves developing expert regulatory strategies and preparing complex submissions for the Australian and New Zealand markets

Job Summary

  • This senior position involves developing expert regulatory strategies and preparing complex submissions for the Australian and New Zealand markets.
  • The role requires extensive experience in the registration of innovator products and the ability to collaborate with international partner companies.
  • Candidates will lead the in-licensing team's contribution to consultation papers and ensure audit readiness for regulatory authorities.

Matching Summary

This senior position 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 or major variations involving clinical data
  • Excellent working knowledge of therapeutic goods legislation and guidelines for Australia and New Zealand

Nice-to-have

  • Strong business acumen and negotiation skills
  • Experience mentoring less experienced team members
  • Ability to work cross-functionally across internal teams

Key Requirements

  • Tertiary qualification in biological science, allied medical discipline, or pharmacy
  • Extensive experience in negotiations with TGA and Medsafe
  • Proven track record in assessing new in-licensing opportunities

Work Rights

Not specified

Tailored Resume

Cover Letter