Global Regulatory Strategy Leader — Senior Director

Otsuka Pharmaceutical Co., Ltd.; United States; Remote; USD 231,000 - 345,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

Prescription drug coverage

401(k) match

Tuition reimbursement

Student loan assistance

Paid time off

Paid holidays

Paid leave programs

Job summary

Otsuka Pharmaceutical Co., Ltd. is seeking an experienced Senior Director to lead global regulatory strategy for a diverse portfolio of development and marketed products.

You will drive enterprise regulatory decisions, govern portfolio plans, and optimize pathways to maximize asset value across the lifecycle. The role requires strong leadership of regulatory teams, extensive health authority interactions, and the ability to align regulatory strategy with development priorities, commercial goals,

Qualifications

• Advanced degree required; PhD, PharmD, MD, or equivalent preferred.
• Minimum 15 years of progressive regulatory affairs experience in pharma/biotech.
• Experience developing and leading global regulatory strategies across multiple programs.
• Proven success influencing portfolio-level decisions and achieving global approvals.
• Experience leading and developing high-performing regulatory teams.

Responsibilities

• Provide strategic leadership for assets in a therapeutic area portfolio across development, registration, commercialization, and lifecycle management.
• Oversee global regulatory milestones (INDs, CTAs, NDAs, BLAs, MAAs) and lifecycle deliverables.
• Lead cross-functional governance and portfolio decision-making with development, clinical, and commercial teams.
• Manage health authority interactions and strategic regulatory negotiations.
• Drive regulatory strategy alignment with enterprise objectives and risk management.

Skills

Global regulatory strategy

Portfolio governance

Regulatory risk management

Executive leadership

Cross-functional collaboration

Education

Advanced degree in scientific discipline

Job description

Otsuka Pharmaceutical Co., Ltd. is seeking an experienced Senior Director to lead global regulatory strategy for a diverse portfolio of development and marketed products.

You will drive enterprise regulatory decisions, govern portfolio plans, and optimize pathways to maximize asset value across the lifecycle. The role requires strong leadership of regulatory teams, extensive health authority interactions, and the ability to align regulatory strategy with development priorities, commercial goals,