Hybrid Director, Regulatory CMC – Global Strategy

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

Benefits offered by this job

401(k) eligibility

Paid time off benefits

Medical benefits

Job summary

Taiho Oncology, Inc. is seeking a Director for Regulatory CMC to manage global regulatory activities for CMC outside Asia.

The role involves strategic guidance, development and submission of regulatory documents, and interactions with authorities across US, EU and other regions, reporting to the Executive Director, Regulatory CMC. You will lead submissions, ensure GMP compliance, coordinate with internal teams and external consultants, and drive regulatory strategies through development,

Qualifications

• Fifteen years’ regulatory CMC drug development experience with 8–10 years in CMC.
• Experience leading CMC documentation for regulatory filings.
• Strong knowledge of global CMC regulatory requirements and GMP.

Responsibilities

• Develop global regulatory CMC strategies and risk assessments.
• Prepare FDA/EMA strategy and submissions plans with cross‑functional teams.
• Coordinate regulatory interactions with authorities and external partners.
• Ensure CMC activities meet global regulatory requirements across lifecycle.
• Lead external consultants and supervise regulatory project status.

Education

Bachelor's degree in pharmacy, chemistry or related scientific discipline

MSc, PhD or PharmD preferred

Tools

FDA/EMA regulatory knowledge

Job description

Taiho Oncology, Inc. is seeking a Director for Regulatory CMC to manage global regulatory activities for CMC outside Asia.

The role involves strategic guidance, development and submission of regulatory documents, and interactions with authorities across US, EU and other regions, reporting to the Executive Director, Regulatory CMC. You will lead submissions, ensure GMP compliance, coordinate with internal teams and external consultants, and drive regulatory strategies through development,