Regulatory Affairs Senior Manager
2 weeks ago
At Gilead Sciences, Inc., we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
About the Role:The Associate Director, Regulatory Affairs will play a key role in leading projects for the Regulatory Affairs team in the ANZ affiliate, working cross-functionally to ensure Gilead complies with the country's applicable legislations and regulations linked to the MA / local license as MA Holder or as local legal representative of the MA Holder.
- Develops and implements regulatory strategies to ensure compliance with local laws and regulations.
- Collaborates with cross-functional teams to achieve regulatory objectives.
- Provides input to the preparation of challenging regulatory submissions.
- Liaises with health authorities and other stakeholders to resolve regulatory issues.
Requirements:
- 12+ years of experience in RA or other relevant industry experience.
- Excellent knowledge and proven experience in understanding and implementing regulatory requirements.
- Strong leadership skills, including project management and team leadership.
- Excellent communication and negotiation skills.
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