Global Regulatory Leader – CNS (Remote)

Sumitomo Pharma; Atlanta (GA); Remote; USD 196,000 - 245,000; Full time

Job summary

Sumitomo Pharma Co., Ltd. in the United States seeks a Global Regulatory Leader to drive regulatory strategy for the CNS portfolio, from proof of concept through post-approval.

The role leads a Global Regulatory Team, collaborates with cross-functional partners, and guides project teams on regulatory submissions and filings. The position is primarily remote with periodic on-site meetings; travel domestically and internationally is required.

Qualifications

• Bachelor’s degree in a related field.
• Minimum 10 years of relevant experience in biotech or pharmaceutical industry.
• Master’s degree required (preferably in a scientific discipline).

Responsibilities

• Leads the Global Regulatory Team (GRT) and regulatory activities for assigned project(s) in line with the global registration strategy.
• Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations on electronic submissions.
• Manages regional regulatory activities (US/Europe) as part of a Global Regulatory Team (GRT).
• Provides updates to GRT, project teams, and governance boards as needed.
• Accounts for developing and maintaining regulatory strategy and documentation.

Skills

Regulatory leadership

FDA/ICH regulations

Regulatory submissions

Global/regional coordination

Team leadership

Education

Bachelor’s degree in a related field

Master’s degree

Job description

Sumitomo Pharma Co., Ltd. in the United States seeks a Global Regulatory Leader to drive regulatory strategy for the CNS portfolio, from proof of concept through post-approval.

The role leads a Global Regulatory Team, collaborates with cross-functional partners, and guides project teams on regulatory submissions and filings. The position is primarily remote with periodic on-site meetings; travel domestically and internationally is required.