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Regulatory Affairs Director

2 weeks ago

Melbourne, Victoria, Australia Gilead Sciences, Inc. Full time

About Gilead Sciences, Inc.

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Gilead Sciences, Inc. is a biopharmaceutical company that creates innovative medicines to treat life-threatening diseases including HIV, hepatitis B, non-alcoholic steatohepatitis (NASH), liver cancer, and cardiovascular disease.

Our mission is to create a healthier world for all people by making transformative medicines accessible to people around the world. We work tirelessly to develop groundbreaking treatments and therapies that help improve lives and ensure access to these treatments across the globe.

We are committed to advancing the science behind our medicines and addressing the complex health challenges facing people today.

About the Role

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  • This role leads the Australia/New Zealand Affiliate Regulatory Affairs function.
  • As a senior regulatory leader, you will be responsible for ensuring compliance with country-specific regulations and guidelines related to marketing authorizations and local licenses.
  • You will also lead cross-functional business partnering, as required, and serve as an affiliate representative in internal and external meetings.
  • The successful candidate will be responsible for ensuring that Gilead complies with applicable legislations and regulations linked to the Marketing Authorization (MA)/local license as MA Holder or as local legal representative of the MA Holder.
  • This includes ensuring that medicinal products in the region can be developed, authorized, and maintained on the market.

Key Responsibilities

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  • Provide vision and direction for the RA organization in Australia/New Zealand, aligning with global/Regional RA Development Organization and Commercial Visions.
  • Ensure that Gilead fulfills all relevant requirements linked to the MA/local license as MA Holder or as local legal representative of the MA Holder for the region.
  • Crisis management functional lead in the region.
  • Responsible for regional resource and budget planning and utilization.
  • Lead communicating important changes to the regional, international, and global Regulatory and Development Organization function/activities.
  • Manage Australia/New Zealand Reg Affiliate team and lead the Regulatory activities.
  • Oversee all regulatory activities in Australia/New Zealand, act as strategic advisor or lead on very complex or challenging issues.

Knowledge & Skills

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  • Expert leadership skills showing ability to influence externally, cross-functionally, and within global Development Organization and RA.
  • Excellent compelling vision and direction setting.
  • Extensive experience working with multiple local HA and Trade Association at a senior level.
  • Expert in developing and implementing regulatory strategies and managing challenging discussions with local HA.
  • Excellent leader of complex cross-functional projects and teams.
  • Expert people management and development experience.
  • Extensive productive cross-functional internal and external networks.
  • Expert influencer, negotiator, and decision-maker.
  • Excellent decision-making and prioritization skills.
  • Excellent verbal and written English language skills, organizational skills, and interpersonal communication skills.