Global Regulatory Strategy Lead

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

Benefits offered by this job

401(k) match

Tuition reimbursement

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Regulatory Affairs professional to develop and execute global regulatory strategies for INDs, CTAs, and marketed products.

You will drive submissions and lifecycle activities in alignment with the Global Regulatory Lead, coordinating with cross-functional teams across regulatory operations, labeling, and medical writing. The role emphasizes regulatory intelligence and health authority interactions, ensuring compliant, timely deliverables

Qualifications

• Experience in pharmaceutical regulatory affairs and submissions (IND/CTA/NDA/BLA).
• Bachelor’s with 5+ years or Master’s with 2+ years in regulatory affairs in pharma/healthcare.
• Familiarity with FDA, ICH regulations and health authority interactions is desirable.

Responsibilities

• Develops and executes global regulatory plans and submissions for INDs, CTAs, amendments and NDAs within timelines.
• Translates global requirements and assesses regulatory challenges for the GRL and teams.
• Collaborates with GRL, regional leads, labeling, medical writing, and regulatory operations to address issues.
• Represents GRA in project teams and provides regulatory guidance to meet timelines.
• Leads preparation and submission of regulatory documents to authorities and ensures high quality output.
• Manages internal staff and external consultants to support assigned projects.

Skills

Regulatory strategy

Regulatory submissions

Regulatory intelligence

Project management

Cross-functional collaboration

Education

Bachelor's degree

Master’s degree in regulatory affairs

Tools

EDMS

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Regulatory Affairs professional to develop and execute global regulatory strategies for INDs, CTAs, and marketed products.

You will drive submissions and lifecycle activities in alignment with the Global Regulatory Lead, coordinating with cross-functional teams across regulatory operations, labeling, and medical writing. The role emphasizes regulatory intelligence and health authority interactions, ensuring compliant, timely deliverables