Senior Director, Global Regulatory Affairs – Biotech Unit

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

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 the 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

• Contribute to the overall partnership program strategy and drive its vision and mission • Develop, implement, and advise on global regulatory strategies for development programs • Manage regulatory aspects of allocated assets through development, post-approval, and product lifecycle • Provide strategic and operational regulatory direction and mentorship • Develop regulatory strategic plans and risk assessments • Manage critical regulatory issues and advise on Health Authority interactions • Oversee preparation and submission of investigational and marketing registration documentation worldwide • Review IND/CTA, NDA/MAA/NDS, and other global submission documents and amendments • Liaise and negotiate with global regulatory authorities on drug development, approvals, and labeling changes • Monitor the global regulatory environment and assess impacts on business and product development programs • Develop regulatory processes and facilitate interpretation of global regulations • Consult with the Advisory Committee and provide guidance to the Execution Unit • Support timely, high-quality planning and execution of associated clinical studies • Conduct regular study review meetings and report study status, goals, and operational and quality KPIs • Champion a global mindset and consistency across Global Regulatory Affairs • Participate in company-wide standards discussions, finalization, and implementation • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree required; advanced degree preferred • Minimum of 12 years in the biotechnology or pharmaceutical industry • Minimum of 5 years in a regulatory leadership capacity • Broad background in oncology • Extensive knowledge of US, China, EU, and ICH regulatory requirements • Experience leading Regulatory Affairs across two or more major geographic areas • Experience leading multiple FDA interactions for oncology products resulting in Agency approval actions • Demonstrated managerial, leadership, and cross-functional collaboration ability • Thorough understanding of the drug development process, pharmaceutical industry, healthcare environment, regulatory requirements, and policy trends • Extensive experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, Health Authority interactions, and regulatory strategy implementation • Proven record of significant regulatory accomplishments • Very strong strategic skills, creativity, and ability to address strategic challenges • Ability to balance short-term needs with long-term vision • Proven ability to deliver goals in a cross-functional team/partnership environment • Excellent interpersonal skills and ability to build positive work relationships across the organization • Fluent in written and verbal English • Mandarin knowledge desirable • Skilled in Microsoft Office Suite • Ability to travel domestically and internationally, up to 20%

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Voluntary Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness benefits • Reasonable accommodation in the job application process