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

Employee Value Proposition:

Join our dynamic and expanding mid-size oncology company in the role of Director, Regulatory CMC, reporting directly to Executive Director, Regulatory CMC.  Your expertise will play a pivotal and visible role in advancing CMC filing strategy for investigational/developmental products (small molecules) in US, EU, UK, Canada, and other ex-US countries/regions.  You will also work with NDA filing, and post-approval/marketing maintenance of approved US NDA, Canada NDS, and other MAA’s.  Working with colleagues in Japan and US will provide you a truly global experience that helps cancer patients to improve quality of life.

The size of our company allows for firsthand interaction with non-clinical/clinical RA and others, clinal operations, supply chain and Qualified Persons.  This position would offer you a well-rounded experience and an exposure to clinical trial applications with newly implemented EU CTR (Clinical Trial Regulations).  Taiho RA-CMC would provide you a platform to showcase and enhance your regulatory-CMC skills.

Position Summary:

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.

Performance Objectives:


* Independently dev...