Director, Regulatory Affairs CMC
Taiho OncologyNew Jersey, United States
Posted December 8, 2025
212500 - 250000 USD
Full Time
About the Company
Taiho Oncology is a Princeton-based oncology company focused on developing and commercializing orally administered small-molecule anti-cancer agents for solid tumors and hematologic malignancies. Leveraging a robust pipeline that spans multiple clinical stages, the firm aims to improve outcomes for patients, families, and caregivers. As a subsidiary of Taiho Pharmaceutical and part of Otsuka Holdings, Taiho Oncology benefits from deep scientific expertise and global resources, with operations in the U.S., Europe, and Canada. Its distinctive approach combines innovative oral therapeutics with a commitment to patient-centric care, positioning it as a leader in targeted cancer treatment.
Job Description
Taiho Oncology is seeking a Director, Regulatory Affairs CMC to join their team in Princeton, NJ. The successful candidate will play a pivotal role in advancing CMC strategy and submissions for developmental, life cycle, and post-approval projects globally, while working with colleagues in Japan and the US to help cancer patients.
Requirements
- Bachelor's degree in pharmacy, chemistry, or related scientific discipline or equivalent experience
- 15 years' previous CMC drug development and regulatory experience (US and EU, preferably) with at least 8-10 years in CMC regulatory or related area
- Substantial experience leading and preparing Chemistry, Manufacturing, and Control (CMC) documentation for regulatory filings
Benefits
- 401(k) eligibility
- Various paid time off benefits (vacation, sick time, parental leave)
- Annual bonus/incentive comp plans
- Potential long-term incentive plan
- Discretionary awards
