Taiho Oncology, Inc. works urgently to discover and develop innovative cancer treatments. As cancer evolves, we evolve with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower us to redefine the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy. Under the direction of regulatory affairs management, the incumbent independently prepares and directs global regulatory affairs activities and provides regulatory guidance during drug development, approval and post approval processes and commercialization, in coordination with both the internal and external consultants and contractors in the oncology therapeutic area. The incumbent initiates interactions and negotiations directly with regulatory authorities during the drug development and approval processes following an agreed upon plan. The incumbent conducts the regulatory activities to ensure high quality, regulatory integrity and completeness of all projects, supporting IND, NDA, MAA, IMPD and CTA submissions.
Responsibilities and Duties:
Other Skills and Abilities:
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The incumbent in the position may be required to perform other duties, as assigned.