Global Regulatory Strategy Manager (Remote)

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

Benefits offered by this job

Comprehensive medical benefits

401(k) match

Paid holidays

Tuition reimbursement

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a regulatory affairs professional to support global regulatory strategy and the planning and execution of submissions for investigational and marketed products.

You will work with the Global Regulatory Lead and cross-functional teams to ensure compliant, timely submissions and lifecycle management. The role requires strong regulatory knowledge, experience with FDA interactions, and excellent communication.

Qualifications

• Bachelor's degree required, 5+ years regulatory affairs experience or Master's with 2+ years.
• Experience with global regulatory submissions (IND, CTA, NDA/BLA, MAA).
• RAC certification a plus.

Responsibilities

• Support development of global regulatory strategy and plan submissions.
• Coordinate submissions to regulatory authorities (INDs, CTAs, NDAs) and ensure timeliness.
• Collaborate with GRL and cross-functional teams to address health authority queries.

Skills

Regulatory strategy

Regulatory submissions

Regulatory intelligence

Communication

Project management

Education

Bachelor's degree

Master's degree

Tools

EDMS

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. is seeking a regulatory affairs professional to support global regulatory strategy and the planning and execution of submissions for investigational and marketed products.

You will work with the Global Regulatory Lead and cross-functional teams to ensure compliant, timely submissions and lifecycle management. The role requires strong regulatory knowledge, experience with FDA interactions, and excellent communication.