Global Regulatory Lead - CNS & NDA Submissions (Remote)

Sumitomo Pharma; Cheyenne (WY); Remote; USD 196,000 - 245,000; Full time

Job summary

Sumitomo Pharma Co., Ltd. in the United States is seeking a Global Regulatory Leader for CNS projects.

The role leads regulatory strategy across proof of concept, development, registration, and post-approval stages, coordinating cross-functional teams and ensuring alignment with global requirements. The position offers a primarily remote work arrangement with periodic on-site meetings, and requires a minimum of 10 years in biotech/pharma, plus a Master’s degree in a scientific field.

Qualifications

• Bachelor’s degree in a related field.
• Minimum 10 years of relevant experience in biotech or pharmaceutical industry.
• Master’s degree preferred, scientific discipline.

Responsibilities

• Leads the Global Regulatory Team (GRT) and regulatory activities for assigned project(s) in line with global strategy.
• Plans, coordinates, authors, and prepares regulatory submissions with Regulatory Operations on electronic submissions.
• Advises team on major regulatory issues and mitigation strategies.
• Maintains compliance with global regulatory requirements and coordinates activities at a global level.
• Travel domestically and internationally as needed.

Skills

Regulatory strategy

Leadership

Regulatory submissions

FDA regulations

ICH guidelines

Cross-functional

Mentoring

Communication

Team collaboration

Regulatory operations

Education

Bachelor’s degree in a related field

Master’s degree in a scientific discipline

Job description

Sumitomo Pharma Co., Ltd. in the United States is seeking a Global Regulatory Leader for CNS projects.

The role leads regulatory strategy across proof of concept, development, registration, and post-approval stages, coordinating cross-functional teams and ensuring alignment with global requirements. The position offers a primarily remote work arrangement with periodic on-site meetings, and requires a minimum of 10 years in biotech/pharma, plus a Master’s degree in a scientific field.