Location: Princeton,NJ, USA
Pleasanton, CA, USA ● Princeton, NJ, USA Req #386
Tuesday, August 20, 2024
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. 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. We invite you to join us.
Hybrid
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 for managing and coordinating the tracking, publishing, submission, and archiving of electronic documents provided to regulatory authorities as well as managing the operational aspects of US, Canada, and European eCTD filings directly or through third-party representation. Responsible for maintaining working knowledge of Regulatory Information Management including evolving EU data requirements. This role leads and participates in Process Improvement initiatives for Regulatory Affairs and TOI Development.
Performance Objectives:
Education/Certification Requirements:
Knowledge, Skills, and Abilities:
The pay range for this position at commencement of employment is expected to be between $178,500 and $210,000 annually. This pay range may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, commissions, and discretionary awards in addition to a full range of medical, financial, and/or other benefits.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time.
Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law.
The incumbent in this position may be required to perform other duties, as assigned.
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