Senior Regulatory Strategist

7 hours ago


Melbourne, Victoria, Australia beBeeregulatory Full time $195,000 - $245,000
About This Opportunity

The role of Associate Director, Regulatory Affairs will play a key part in driving projects forward for the Regulatory Affairs team within the ANZ affiliate.

Key Responsibilities:
  • Strategic Leadership: Contribute to the development of the RA organization's vision and direction at a country level.
  • Regulatory Compliance: Ensure that Gilead meets all relevant requirements linked to market authorization/local license.
  • Submission Preparation: Lead or provide input to the preparation of challenging regulatory submissions.
  • Country Advice: Lead or support country/national scientific advice and/or pre-submission meeting preparation and follow-up.
  • Regulatory Strategy: Develop and implement regulatory strategies and manage complex discussions with local health authorities.
Required Skills and Qualifications:
  • Leadership Skills: Ability to influence externally, cross-functionally, and within global RA.
  • Vision Setting: Strong vision and direction setting skills.
  • Experience Working with Local HA: Extensive experience working with local health authorities at a senior level.
  • Regulatory Expertise: Must be capable of developing and implementing regulatory strategies and managing complex discussions with local health authorities.

Gilead is committed to creating an inclusive work environment. All employment decisions are made without discrimination based on non-job-related characteristics.



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