Global Regulatory Strategy Director — Portfolio Leadership

Otsuka Pharmaceutical Co., Ltd; Northern (KY); Hybrid; USD 231,000 - 345,000; Full time

Job summary

Otsuka Pharmaceutical Co., Ltd seeks a Senior Director, Global Regulatory Strategy to lead regulatory strategy across a portfolio of development and marketed products. You will drive global regulatory decisions, manage lifecycle activities, and align strategy with development and business objectives.

The role requires advanced degree and 15+ years of experience in regulatory affairs, with a proven track record in major markets and high-level health authority negotiations, aiming to maximize

Qualifications

• Advanced degree in a scientific discipline required; PhD, PharmD, MD, or equivalent preferred.
• Minimum 15 years of progressive regulatory affairs experience within pharma/biotech.
• Significant experience leading global regulatory strategies across multiple programs.

Responsibilities

• Provide strategic leadership for regulatory strategy and portfolio governance across development, registration, and lifecycle management.
• Oversee major global regulatory milestones and lifecycle deliverables with cross-functional teams.
• Lead high-impact health authority interactions and regulatory negotiations.
• Mentor regulatory leads and ensure alignment with enterprise objectives.
• Drive continuous improvement and governance for regulatory processes.

Skills

Regulatory strategy leadership

Portfolio governance

Health authority negotiations

Cross-functional leadership

Executive stakeholder management

Education

PhD in scientific discipline

PharmD or MD preferred

Job description

Otsuka Pharmaceutical Co., Ltd seeks a Senior Director, Global Regulatory Strategy to lead regulatory strategy across a portfolio of development and marketed products. You will drive global regulatory decisions, manage lifecycle activities, and align strategy with development and business objectives.

The role requires advanced degree and 15+ years of experience in regulatory affairs, with a proven track record in major markets and high-level health authority negotiations, aiming to maximize