Senior Director, Global Regulatory Affairs – Biotech Unit
$211,200–$281,200 year
RemoteUnited States
Job Summary
Provide high-level strategic and operational regulatory direction for development programs, securing market access for oncology products across US, China, EU, and ICH jurisdictions. Oversee preparation and submission of IND/CTA, NDA/MAA documentation while liaising with global regulatory authorities to resolve key issues and expedite approvals. Mentor the Execution Unit on study planning, quality KPIs, and timelines through regular review meetings and critical issue management. Develop global regulatory strategies and standard interpretations, balancing short-term operational needs with long-term vision for the partnership program. Manage allocated assets through all development phases, ensuring compliance with local requirements and facilitating policy development.
Required Qualifications
- Bachelor's degree
- Advanced degree preferred
- 12 years in the biotechnology or pharmaceutical industry
- 5 years in a regulatory leadership capacity
- Broad background in oncology
- Experience of working as a lead in Regulatory Affairs across two or more major geographic areas
- Experience of leading multiple FDA interactions for oncology products leading to Agency approval actions
- Experience should clearly be demonstrative of managerial, leadership, and collaboration ability across multiple functional areas
- Thorough understanding of drug development process, the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
- Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, developing, and implementing regulatory strategies with a proven track record of significant regulatory accomplishments
- Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges and the ability to balance short-term needs with long-term vision
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
- Excellent interpersonal skills and the ability to build and maintain positive work relationships to effectively interface at all levels across the organization
- Fluent in written and verbal English
- Mandarin
Desired Qualifications
- Master's degree
- Knowledge of Mandarin
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