Taiho Oncology
Director, CMC Regulatory Affairs (Project Management)
Looking for a chance to make a real difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also value our employees, who work relentlessly to help us execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of our patients, our partners, and each other. Together, we're working to discover and develop innovative cancer treatments that address unmet patient needs and apply the science behind them in novel ways. As the field of cancer treatment evolves, we evolve with it. Advanced technology, dedicated investigators, and incomparable facilities: these vast resources empower us to redefine the way the world treats cancer. It's our work, our passion, and our legacy. If the prospect of being part of this sounds exciting, we invite you to join us.
Hybrid Role: 2-3 days a week in office
Position Summary:
With minimal direction from the Global Senior Director, Regulatory Affairs, the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug development, approval and post approval processes and commercialization, in coordination with internal staff, Japanese colleagues at Taiho Pharmaceutical Corporation (TPC) and external consultants/contractors. Manages the development and preparation of high-quality regulatory submissions including NDA's, MAA's, INDs, CTAs, DMFs, ASMFs, etc. and ensures that they conform to current GMP and meet global regulatory requirements. The incumbent may participate in interactions and negotiations with regulatory authorities during the drug development and approval processes following an agreed upon plan.
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#Location-Princeton-NJ