Remote: Global Regulatory Strategy Lead

Otsuka America Pharmaceutical Inc.; Dover (DE); Remote; USD 150,000 - 224,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. seeks an experienced regulatory affairs professional to support global regulatory strategy and submissions. You will coordinate with GRL, regional leads, and cross-functional teams to address health authority queries and meet timelines.

The role requires 5+ years in regulatory affairs or related areas, with FDA/ICH knowledge and strong communication skills. Occasional travel and a focus on quality documentation are essential.

Qualifications

• Experience preparing global regulatory submissions (IND/CTA/NDA/BLA).
• Knowledge of FDA/ICH regulations and guidelines.
• RAC certification a plus.

Responsibilities

• Support global regulatory strategy and execution of submissions.
• Coordinate regulatory activities with GRL, project teams, and experts.
• Prepare INDs, CTAs, amendments, and aggregate reports.
• Ensure submission documents are accurate and compliant.

Skills

Regulatory affairs

Regulatory strategy

Communication skills

Project management

Education

Bachelor's degree in regulatory affairs or related field

Tools

Microsoft Office

EDMS

Job description

Otsuka America Pharmaceutical Inc. seeks an experienced regulatory affairs professional to support global regulatory strategy and submissions. You will coordinate with GRL, regional leads, and cross-functional teams to address health authority queries and meet timelines.

The role requires 5+ years in regulatory affairs or related areas, with FDA/ICH knowledge and strong communication skills. Occasional travel and a focus on quality documentation are essential.