Director, Regulatory Affairs CMC

Looking for a chance to make a meaningful 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 highly value our employees, who work relentlessly to help 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 patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients.

It’s our work, our passion, and our legacy. We invite you to join us.

Hybrid: 3-days per week on‑site

Join our dynamic and expanding mid‑size company in the role of Director for Regulatory CMC directly reporting to Executive Director, Regulatory CMC. Your expertise will play a pivotal and visible role in advancing CMC strategy and submissions of developmental, life cycle and post approval projects in US, EU, Canada and more, working with colleagues in Japan and US, giving you a truly global experience that helps cancer patients every day.

The size of our company allows for firsthand interaction with multiple functions within our organization, offering you a well‑rounded experience and a platform to showcase and enhance your skills.

With minimal direction 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.

• Independently develops global regulatory CMC Strategies and Risk Assessments and communicate such strategies and risks to TPC and also within TOI.
• Prepare strategy and plans for FDA/EMA meetings in coordination with TPC and TOI members. Ensure rapid preparation and approval of CMC meeting related submissions to health agencies and resolution of queries. Participate in interactions and negotiations with regulatory authorities.
• Provides strategic regulatory guidance, especially CMC during drug development, approval and post approval in coordination with both internal and external staff, consultants and contractors.
• Ensures that the pharmaceutical development, manufacturing and testing of drug substance and drug product conforms to current global regulatory requirements.
• Leads, coordinates and prepares CMC submissions to regulatory authorities globally except Asia.
• Review submissions for regulatory compliance and completeness.
• Responsible for developing submission strategy for assigned projects and specific areas of expertise with assistance.
• Responsible for development of strategy and risk assessments for CMC activities (e.g., INDs, IMPDs, MAAs/Post approval…