Director - Global Regulatory Lead

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July 17

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BeOne Medicines

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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

• Responsible for developing, implementing, and advising on global regulatory strategies • Manage regulatory aspects of compounds through all phases of development • Provide leadership and strategic regulatory oversight for designated projects • Interface with business partners regarding global development and registration strategies • Support the preparation and submission of global regulatory documentation • Maintain awareness of global regulatory environment • Facilitate policy and development of standard interpretation of global regulation • Manage and lead an effective global regulatory project team • Mentor regulatory professionals and help create a goal oriented culture

🎯 Requirements

• BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years of experience in the biotechnical or pharmaceutical industry • 5+ years of experience in a Regulatory capacity with broad and in-depth regulatory knowledge • Experience working as a lead in Regulatory Affairs across two or more major geographic areas • Prior experience with both small molecules and biologics • Sufficient regulatory knowledge to integrate inputs from other countries/regions • Thorough understanding of drug development process and the pharmaceutical industry • Understands scientific and clinical data sufficiently to ask questions and make suggestions • Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness