Global Regulatory Leader, CNS (Remote)

Sumitomo Pharma; Phoenix (AZ); Remote; USD 196,000 - 245,000; Full time

Benefits offered by this job

401(k) plan

Medical/Dental/Vision insurance

Paid time off

Flexible leave policy

Job summary

Sumitomo Pharma Co., Ltd. US-based remote role leads development and implementation of regulatory strategy for CNS projects, serving as Global Regulatory Leader or Regional Regulatory Leader, coordinating cross-functional teams.

The role emphasizes autonomy, mentorship, preparing submissions, liaising with FDA/ICH, and travel for on-site meetings as needed; requires 10+ years in biotech/pharma and a Master’s degree.

Qualifications

• Experience leading regulatory strategy for biotech/pharma programs.
• Strong understanding of FDA/ICH guidelines and regulatory pathways.
• Ability to work in a matrix organization and mentor junior staff.

Responsibilities

• Lead Global Regulatory Team (GRT) and regulatory activities for assigned projects.
• Coordinate regional regulatory activities (US/Europe) as part of GRT.
• Plan, author, and submit regulatory documents and interact with Health Authorities.
• Mentor junior staff and ensure regulatory compliance across submissions.

Skills

Regulatory leadership

FDA/ICH regulations

Global/Regional strategy

Education

Bachelor's degree

Master's degree

Tools

Regulatory Submissions

Job description

Sumitomo Pharma Co., Ltd. US-based remote role leads development and implementation of regulatory strategy for CNS projects, serving as Global Regulatory Leader or Regional Regulatory Leader, coordinating cross-functional teams.

The role emphasizes autonomy, mentorship, preparing submissions, liaising with FDA/ICH, and travel for on-site meetings as needed; requires 10+ years in biotech/pharma and a Master’s degree.