Global Regulatory Leader – Remote (CNS & Biopharma)

Sumitomo Pharma; Honolulu (HI); Remoto; USD 196.000 - 245.000; Tempo integral

Resumo da vaga

Sumitomo Pharma America (SMPA) seeks a seasoned Regulatory Leader to guide global/regional regulatory strategy for CNS projects. You will own submissions, coordinate across functions, and ensure compliance with FDA/ICH guidelines across global teams.

In this role, you lead a cross‑functional team, mentor junior staff, and operate with substantial autonomy. This remote US position collaborates with global partners and travels as needed.

Qualificações

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

Responsabilidades

• Lead the Global Regulatory Team (GRT) and regulatory activities for assigned project(s).
• Coordinate regional regulatory activities in the US/Europe as part of GRT.
• Plan, authors, and prepares regulatory submissions with Regulatory Operations.
• Provide updates to the GRT and project teams as needed.

Conhecimentos

Global Regulatory Leadership

Regulatory Strategy

Cross-functional Leadership

Regulatory Submissions

FDA/ICH Regulations

Formação

Bachelor's degree in related field

Master's degree in related field

Descrição da vaga

Sumitomo Pharma America (SMPA) seeks a seasoned Regulatory Leader to guide global/regional regulatory strategy for CNS projects. You will own submissions, coordinate across functions, and ensure compliance with FDA/ICH guidelines across global teams.

In this role, you lead a cross‑functional team, mentor junior staff, and operate with substantial autonomy. This remote US position collaborates with global partners and travels as needed.