Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology

Location: Remote – US-based candidates only, no visa sponsorship available

Compensation: $215,204 – $291,159 annually

About the role

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations. The position offers the opportunity to strengthen responsible execution, improve decision-making, and support sustainable growth within a life sciences environment.

Responsibilities

• Develop and execute global regulatory product strategies for complex, late-stage assets
• Lead Global Regulatory Teams (GRTs) and advise on regulatory objectives
• Create comprehensive Global Regulatory Strategic Plans from cross-functional input
• Direct interactions and planning for global regulatory filings, including marketing applications
• Monitor global regulations and advise teams on relevant changes and implications
• Communicate regulatory strategies and risks to ensure understanding of success probabilities
• Guide regulatory processes and improvements at the organizational level

Qualifications

• Doctorate degree with 5 years of regulatory experience in biotech or science, or a Master's degree with 9 years, or a Bachelor's degree with 11 years of relevant experience
• Minimum of 5 years in a management or leadership role, directing teams or projects
• Experience in late-stage regulatory strategy for high complexity programs
• Demonstrated oncology expertise is a plus
• Strong abilities in team leadership, communication, and negotiation

Benefits

• Comprehensive employee benefits package, including medical, dental, and vision coverage
• Retirement and Savings Plan with company contributions
• Flexible work models where applicable
• Award-winning time-off plans to promote work-life balance
• Discretionary annual bonus program and stock-based long-term incentives