Remote Senior Director, Global Regulatory Strategy

Otsuka America Pharmaceutical Inc.; Cheyenne (WY); Remote; USD 231,000 - 345,000; Full time

Benefits offered by this job

Comprehensive health benefits

Generous 401(k) match

Paid holidays & leaves

Flexible time off

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Regulatory Strategy to lead regulatory strategy across a therapeutic area portfolio, spanning development, registration, and lifecycle management.

You will guide portfolio planning, governance, and risk management, ensuring alignment with global development plans and business objectives. As a member of the Regulatory Leadership Team, you will influence regulatory pathways, drive execution of major submissions, and mentor

Qualifications

• Advanced degree in a scientific discipline required; PhD, PharmD, MD, or equivalent preferred.
• Significant experience in regulatory affairs within pharma/biotech.
• Proven ability to lead global regulatory strategies across programs.

Responsibilities

• Provide strategic leadership for assets in a therapeutic area portfolio across development, registration, and lifecycle management.
• Oversee global regulatory milestones (INDs, CTAs, NDAs, MAAs) and lifecycle deliverables.
• Lead health authority interactions and strategic negotiations with global authorities.
• Partner with cross-functional teams to drive integrated decision-making and governance.

Skills

Strategic leadership

Global regulatory strategy

Portfolio governance

Regulatory submissions

Cross-functional collaboration

Education

Advanced scientific degree

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Regulatory Strategy to lead regulatory strategy across a therapeutic area portfolio, spanning development, registration, and lifecycle management.

You will guide portfolio planning, governance, and risk management, ensuring alignment with global development plans and business objectives. As a member of the Regulatory Leadership Team, you will influence regulatory pathways, drive execution of major submissions, and mentor