BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.
10,000+ employees
Founded 2010
Director, Regulatory Affairs, Dx/CDx, Medical Devices
October 11
BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.
10,000+ employees
Founded 2010
📋 Description
• Lead a small team for developing and implementing regulatory diagnostic and medical device strategies • Develop European and/or UK regulatory strategy for the designated program • Act as the representative of European regulatory team at the global regulatory team (GRT) • Provide direction and oversight for Dx/CDx and Device related content of regulatory documents • Identify potential risks and propose solutions/mitigation plans for successful acceptance of submissions • Oversee Dx/CDx and Device related regulatory agency communications, submissions, and approvals • Maintain up-to-date working knowledge of laws, regulations, and guidelines • Represent the BeOne European regulatory function at industry consortium
🎯 Requirements
• Minimum of 10+ years’ experience in the biotechnical or pharmaceutical industry • Bachelor's degree • Minimum of 10 years’ experience in a Regulatory capacity with increasing responsibility • Strong background in medical devices/diagnostic development regulations • Experience working with Notified Bodies and various Member State HAs • Recent experience with diagnostic testing to support clinical trials • Proven ability to deliver on goals within a cross-functional team environment • English native speaker preferred
🏖️ Benefits
• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness
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