Remote Global Regulatory Strategy Director

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

Benefits offered by this job

Comprehensive medical, dental, vision

Tuition reimbursement

401(k) match

Paid holidays

Paid leave programs

Flexible time off

Employee assistance programs

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Regulatory Strategy to lead strategic regulatory initiatives across development and commercialization.

The role drives global regulatory planning, submissions, and lifecycle management for a therapeutic area portfolio, while partnering with cross-functional teams and senior leadership. As part of the Global Regulatory Leadership Team, you will optimize pathways, manage portfolio risks, and guide regulatory decision-making to

Qualifications

• Advanced degree in a scientific discipline; PhD, PharmD, MD or equivalent preferred.
• Minimum 15 years of progressive regulatory affairs experience in pharma/biotech.
• Experience leading global regulatory strategies across multiple programs.
• Proven track record influencing portfolio decisions and approvals.

Responsibilities

• Provide strategic leadership for global regulatory strategy across portfolio.
• Oversee major regulatory milestones including INDs, CTAs, NDAs, and MAAs.
• Lead health authority engagements and strategic negotiations.
• Mentor and develop a high-performing regulatory team.
• Ensure compliant, efficient submissions and lifecycle management.
• Align regulatory plans with development priorities and business goals.

Skills

Strategic leadership

Global regulatory strategy

Regulatory submissions

Regulatory risk management

Cross-functional collaboration

Team development

Education

Advanced degree in a scientific discipline (PhD/PharmD/MD preferred)

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Regulatory Strategy to lead strategic regulatory initiatives across development and commercialization.

The role drives global regulatory planning, submissions, and lifecycle management for a therapeutic area portfolio, while partnering with cross-functional teams and senior leadership. As part of the Global Regulatory Leadership Team, you will optimize pathways, manage portfolio risks, and guide regulatory decision-making to