Director, Global CMC Regulatory Strategy

Taiho Oncology, Inc.; Pleasanton (CA); Hybrid; USD 213,000 - 250,000; Full time

Benefits offered by this job

401(k) eligibility

Paid time off

Medical benefits

Job summary

Taiho Oncology, Inc. seeks a senior Director to lead global regulatory CMC activities, coordinating strategy, submissions, and approvals across US, EU, and other regions.

This role partners with internal teams and external consultants to ensure compliant development and post-approval activities. With extensive CMC expertise, you will influence regulatory strategies, manage interactions with authorities, and drive submission planning for NDA/MAA developments, while guiding teams across functions

Qualifications

• Fifteen years’ CMC development and regulatory experience (US/EU preferred).
• At least 8–10 years in CMC regulatory or a related area.

Responsibilities

• Develops global CMC regulatory strategy and risk assessments.
• Prepare FDA/EMA meeting strategy and submissions.
• Lead CMC submissions to regulatory authorities globally (excluding Asia).
• Coordinate regulatory guidance with internal teams and external consultants.
• Ensure GMP compliance and alignment with global regulatory requirements.
• Oversee regulatory support for product lifecycle from development to post-approval.

Skills

Global regulatory strategy

FDA/EMA negotiation

CMC project leadership

Regulatory submissions

Regulatory guidance

Regulatory compliance

Strong written/oral communication

Cross-functional collaboration

Education

Bachelor’s degree in pharmacy/chemistry

MSc/PhD/PharmD preferred

Job description

Taiho Oncology, Inc. seeks a senior Director to lead global regulatory CMC activities, coordinating strategy, submissions, and approvals across US, EU, and other regions.

This role partners with internal teams and external consultants to ensure compliant development and post-approval activities. With extensive CMC expertise, you will influence regulatory strategies, manage interactions with authorities, and drive submission planning for NDA/MAA developments, while guiding teams across functions