Global Regulatory Leader — CNS Biopharma (Remote)

Sumitomo Pharma; Trenton (NJ); Remote; USD 196,000 - 245,000; Full time

Job summary

Sumitomo Pharma is seeking a Senior Regulatory Leader to spearhead regulatory strategy for CNS projects in the US. The role reports to the Executive Director, Regulatory Affairs, within the Biopharma R&D Regulatory Affairs group.

You will drive global/regional regulatory activities with cross-functional teams, and mentor junior staff as needed. The position requires a Bachelor’s degree, 10+ years of regulatory experience in biotech/pharma, and a Master’s degree is preferred.

Qualifications

• Bachelor’s degree required in a related field.
• Minimum 10 years of relevant biotech/pharma regulatory experience.
• Master’s degree is preferred for leadership in regulatory strategy.

Responsibilities

• Lead Global Regulatory Team (GRT) and regulatory activities per global strategy.
• Serve as Regional Regulatory Lead for US/Europe as part of GRT.
• Coordinate and author regulatory submissions and liaise with Regulatory Operations on e-submissions.
• Advise on major regulatory issues and mitigation strategies.

Skills

Regulatory strategy

Global/Regional leadership

FDA regulations

ICH guidelines

Regulatory submissions

Education

Bachelor’s degree in a related field

Master’s degree in a scientific discipline

Job description

Sumitomo Pharma is seeking a Senior Regulatory Leader to spearhead regulatory strategy for CNS projects in the US. The role reports to the Executive Director, Regulatory Affairs, within the Biopharma R&D Regulatory Affairs group.

You will drive global/regional regulatory activities with cross-functional teams, and mentor junior staff as needed. The position requires a Bachelor’s degree, 10+ years of regulatory experience in biotech/pharma, and a Master’s degree is preferred.