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BeOne Medicines Ltd is seeking a remote Director, Global Regulatory Lead to develop and implement regulatory strategies for oncology products, ensuring market access in line with business objectives. The ideal candidate will possess extensive experience in regulatory affairs within the biopharmaceutical industry, focusing on hematology assets, and will lead cross-functional teams while fostering collaboration.
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Job Summary
The Director, Global Regulatory Lead will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.
This individual will manage regulatory aspects of compounds through all phases of development, post-approval, and life-cycle of the product.
BeOne is committed to fair and equitable compensation practices, offering a comprehensive benefits package including Medical, Dental, Vision, 401(k), and equity opportunities.
Matching Summary
Match Score: 75
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BeOne Medicines Ltd is seeking a remote Director, Global Regulatory Lead to develop and implement regulatory strategies for oncology products, ensuring market access in line with business objectives. The ideal candidate will possess extensive experience in regulatory affairs within the biopharmaceutical industry, focusing on hematology assets, and will lead cross-functional teams while fostering collaboration.
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Salary
Base: $176,000.00 - $236,000.00 annually; Bonus/Equity: Annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness
Skills & Requirements
Must-have
Global regulatory strategies
Drug development process
Health Authority interactions
Lifecycle management
Nice-to-have
Fighting cancer passion
Collaborative spirit
Bold ingenuity
Key Requirements
BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years of experience
5+ years of experience in a Regulatory capacity
Experience with INDs/CTAs, NDAs/BLAs/MAAs
Experience leading cross-functional regulatory teams