Senior Director, Regulatory Affairs

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Senior Director, Regulatory Affairs is accountable for developing, implementing, shaping US regulatory direction and U.S. Food and Drug Administration engagement across a development portfolio and marketed products to achieve timely approvals and sustain product value in alignment with business objectives and the global regulatory strategy. This individual provides strategic leadership across all phases of development, registration, post-approval commitments, and lifecycle management, with primary responsibility for U.S. FDA interactions. The incumbent anticipates changes in the U.S. regulatory and healthcare environment, assesses their impact on portfolio and program strategy, and translates complex requirements into clear recommendations for senior management and cross-functional governance decisions, and provides direction on significant regulatory risks. The Senior Director serves as a senior regulatory advisor, leads resolution of critical regulatory issues, and influences program and portfolio decisions through sound judgment, scientific rigor, and business acumen. The role may provide line management, organizational leadership, talent development, and oversight of departmental policies, standards, and continuous-improvement initiatives. Essential Functions of the job: ·       Leads the development and execution of integrated U.S. regulatory strategies for assigned products and programs across clinical development, registration, post-approval commitments, and lifecycle management. Provides authoritative U.S. regulatory advice to global regulatory leaders, development teams, governance committees, and senior management, including assessment of strategic options, risks, trade-offs, and mitigation plans. Integrating US regulatory considerations and advice in collaboration with the global regulatory team to contribute to create an integrated global strategy. Serves as the primary regulatory leader for FDA engagement; plans, leads, and negotiates formal and informal interactions to resolve critical issues and advance development and approval objectives. Oversees the strategy, preparation, quality, and timely submission of INDs, NDAs, BLAs, supplements, amendments, meeting packages, briefing documents, responses to information requests, and other U.S. regulatory filings. ·       Ensures U.S. regulatory requirements and FDA expectations are incorporated into clinical development plans, evidence-generation strategies, labeling plans, and commercialization and lifecycle decisions. ·       Leads regulatory risk assessment and critical issue management, escalating significant risks with clear options and…