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 Sr. Manager/Associate Director, Advertising/Promotion Regulatory Affairs is responsible for overseeing the regulatory assessment and research on regulatory precedence, in order to evaluate advertising/promotional regulatory issues for Taiho Oncology products; develop and review regulatory strategies for promotional materials for marketed and pipeline products; provide regulatory input to various functional units on promotional labeling for marketed and to-be marketed drugs, and may serve as a the lead regulatory affairs representative on the PRC committee. The incumbent independently prepares and directs global regulatory affairs activities and provides regulatory guidance during drug development, approval and post approval processes.
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 this position may be required to perform other duties, as assigned.