Associate Director, Regulatory Affairs Operations

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 Associate Director, Regulatory Affairs Operations where you will utilize your knowledge and experience to build a stronger Regulatory Operations team by providing guidance, as well as regulatory system and process support for the US and Europe.

At Taiho Oncology our mission is to improve the lives of patients with cancer, their families, and their caregivers.

Whether it’s our patients or employees, people come first at Taiho.

The compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most.

Our culture is inclusive, and our leadership ensures an environment which encourages employees to be accountable for their own successes.

Collaboration and trust are additional core principles operating at Taiho which sets us apart from other organizations.

These principles foster open communication and fun atmosphere.

Respect, dignity, compassion and kindness are required of each employee.

We believe that honesty and integrity are critical to our business and our actions earn each other’s trust and the trust of the community we serve.

Position Summary: 

Under the leadership of Regulatory Affairs the incumbent manages global regulatory operational activities (except Asia) for all Taiho Oncology, Inc., (TOI) projects, provides strategic regulatory operational guidance during drug development, approval, post approval, and commercialization, in coordination with internal staff and external consultants/contractors.

Coordinate the publishing and submission of electronic documents to regulatory authorities.

This role is responsible to manage and coordinate the tracking, publishing, submission and archiving of electronic documents provided to regulatory authorities as well as manage the operational aspects of US, Canada and European eCTD filings directly or thr...