Director, Global Regulatory CMC

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

Job summary

Taiho Oncology is seeking a Director for Regulatory CMC to lead global regulatory activities across US, EU, Canada and more, reporting to the Executive Director, Regulatory CMC. You will collaborate with global colleagues, including teams in Japan and the US, to drive CMC strategy for development, lifecycle and post-approval projects.

The role requires extensive experience in CMC regulatory submissions, GMP compliance, and interactions with regulatory authorities.

Qualifications

• 15 years’ CMC regulatory experience (US & EU preferred) with 8–10 years in CMC regulatory
• Leads development and submission of CMC documentation for regulatory filings
• Strong experience interacting and negotiating with regulatory authorities (FDA/EMA)

Responsibilities

• Develop global regulatory CMC strategies and risk assessments
• Prepare FDA/EMA meeting strategy and related submissions
• Provide strategic regulatory guidance throughout development, approval, and post-approval
• Ensure GMP compliance across pharmaceutical development, manufacturing and testing
• Lead CMC submissions globally excluding Asia

Skills

CMC regulatory strategy

Regulatory submissions

FDA negotiations

Global regulatory expertise

Drug development knowledge

Education

Bachelor’s in Pharmacy/related

Advanced degree preferred

Job description

Taiho Oncology is seeking a Director for Regulatory CMC to lead global regulatory activities across US, EU, Canada and more, reporting to the Executive Director, Regulatory CMC. You will collaborate with global colleagues, including teams in Japan and the US, to drive CMC strategy for development, lifecycle and post-approval projects.

The role requires extensive experience in CMC regulatory submissions, GMP compliance, and interactions with regulatory authorities.