Global Regulatory Strategy Director — CNS (US Remote)

Sumitomo Pharma; Santa Fe (NM); Remote; USD 196,000 - 245,000; Full time

Job summary

Sumitomo Pharma is seeking a senior Regulatory Affairs leader to act as Global Regulatory Leader or Regional Regulatory Leader for CNS projects in the US. The role requires building regulatory strategy from concept through post-approval and coordinating with cross-functional teams.

The position demands 10+ years in biotech/pharma, a Bachelor’s degree (Master’s preferred), and strong experience with FDA/ICH guidance and regulatory submissions.

Qualifications

• Bachelor’s degree required.
• Master’s degree preferred (scientific discipline).
• Minimum 10 years of relevant experience in biotech/pharmaceutical industry.

Responsibilities

• Lead Global Regulatory Team (GRT) and regulatory activities aligned with global strategy.
• Manage regional regulatory activities US/Europe as part of GRT.
• Plan, author, and coordinate regulatory submissions and interactions with Health Authorities.
• Develop regulatory strategy documents and drive ERS for CNS portfolio.
• Mentor junior staff and provide strategic regulatory guidance.

Skills

Global regulatory leadership

Regulatory strategy

Regulatory submissions

FDA/ICH knowledge

Team mentoring

Education

Bachelor’s degree

Master’s degree

Job description

Sumitomo Pharma is seeking a senior Regulatory Affairs leader to act as Global Regulatory Leader or Regional Regulatory Leader for CNS projects in the US. The role requires building regulatory strategy from concept through post-approval and coordinating with cross-functional teams.

The position demands 10+ years in biotech/pharma, a Bachelor’s degree (Master’s preferred), and strong experience with FDA/ICH guidance and regulatory submissions.