Global Regulatory Strategy Leader - IND/NDA Submissions

Otsuka Pharmaceutical Co., Ltd; Northern (KY); Hybrid; USD 150,000 - 224,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks an experienced Regulatory Affairs professional to develop and execute global regulatory strategy for investigational and marketed prescription drugs, coordinating with the Global Regulatory Lead and cross‑functional teams.

You will manage submissions (INDs, NDAs/MAAs), regulatory intelligence, health authority interactions, and lifecycle activities, ensuring compliance with FDA/ICH and EDMS practices; travel approx. 20%.

Qualifications

• Bachelor’s degree in regulatory affairs or related field with 5+ years’ experience in regulatory affairs.
• Master’s degree in regulatory affairs or related field with 2+ years’ experience is acceptable.

Responsibilities

• Develop global regulatory strategy and plan for investigational and marketed products.
• Lead and coordinate regulatory submissions (INDs, CTAs, NDAs/MAAs) and responses to health authorities.
• Provide regulatory intelligence and assessment of global requirements to GRL and project teams.
• Collaborate with GRL, regional leads, and cross-functional teams to address regulatory issues and obligations.
• Ensure documents are accurate, compliant, and high-quality for approvals.
• Interact with health authorities and act as sponsor contact when needed.
• Drive departmental initiatives to improve efficiency, quality, and output.

Skills

Regulatory strategy

Regulatory intelligence

Regulatory submissions

Cross-functional leadership

FDA/ICH knowledge

EDMS familiarity

MS Office proficiency

Education

Bachelor's degree in regulatory affairs or related field

Master's degree in regulatory affairs or related field

Tools

EDMS

Microsoft Office

Job description

Otsuka Pharmaceutical Co., Ltd. seeks an experienced Regulatory Affairs professional to develop and execute global regulatory strategy for investigational and marketed prescription drugs, coordinating with the Global Regulatory Lead and cross‑functional teams.

You will manage submissions (INDs, NDAs/MAAs), regulatory intelligence, health authority interactions, and lifecycle activities, ensuring compliance with FDA/ICH and EDMS practices; travel approx. 20%.