Senior Director, Global Regulatory Affairs - Biotech Unit

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

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

• Provide strategic regulatory direction for projects
• Oversee preparation and submission of global regulatory documentation
• Liaise with global regulatory authorities on drug development issues
• Ensure compliance with global regulatory requirements across development phases
• Mentor and guide cross-functional teams in study planning and execution

Qualifications

• Bachelor’s degree required; advanced degree preferred
• Minimum of 12 years in biotechnology or pharmaceutical industry
• At least 5 years in a regulatory leadership role, especially in oncology
• Experience leading regulatory affairs across multiple geographic areas
• Proven track record with INDs/CTAs, NDAs/BLAs/MAAs and regulatory strategies

Pay

$211,200 – $281,200 annually

Benefits

• Eligibility for annual bonus and discretionary equity awards
• Participation in Employee Stock Purchase Plan
• Comprehensive health coverage including Medical, Dental, and Vision
• 401(k) plan with employer contributions
• Paid Time Off and Wellness programs