BeOne Medicines
10,000+ employees
Founded 2010
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.
Associate Director, Regulatory Affairs
🕒 May 6
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BeOne Medicines
10,000+ employees
Founded 2010
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.
📋 Description
• Manage, evaluate, and complete regulatory projects • Develop, implement, and advise on regulatory strategies • Responsible for managing decision-making and conflict resolution • Oversee the preparation and submission of documentation • Liaise and negotiate with regulatory authorities • Maintain awareness of regulatory environment and assess impact of changes
🎯 Requirements
• Bachelor’s degree with 8+ years’ of related regulatory experience • Experience working as a Project Lead in Regulatory Affairs • Experience with INDs/CTAs, NDAs/BLAs/MAAs • Lifecycle management • Interactions with Health Authorities • Current knowledge of FDA perspectives, precedents, and guidances • Excellent verbal and written skills
🏖️ Benefits
• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness
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