Taiho Oncology

  • Associate Director, Regulatory Affairs

    Job Locations US-NJ-Princeton
    Regular Full-Time
  • Position Summary

    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:


    • Independently directs as well as prepares global regulatory affairs strategies and executes regulatory activities for Taiho Oncology, Inc., (TOI), with general guidance from manager and regulatory affairs leadership.
    • Fosters collaborative, efficient, and effective working relations with FDA (and other Health Authorities if necessary) in order to further build the cordial working relationship between Taiho Oncology, Inc. and global health authorities.
    • Assesses the impact on new regulations, guidances or enforcements and advises the project teams on requirements to maintain compliance with regulatory activities with emphasis on research and development activities.
    • Advises the relevant project teams and management on relevant new and existing regulatory risks and compliance requirements relevant to development aspects. Provides regulatory expertise, advice, and support to the TOI Development Organization and other product-related teams. Fosters and facilitate communication with Global Regulatory Affairs on these topics.
    • Contributes to the development and implementation of Corporate and Department procedures for regulation of development programs.
    • Prepare project and/or status reports as required.
    • This position requires travel.


     Educational Requirements:  


    • Bachelor’s degree in pharmacy, biology, chemistry or related scientific discipline or equivalent experience is required.
    • MSc, PhD or PharmD preferred.
    • Optional RAC certification helpful.
    • Technical and scientific expertise in a discipline related to pharmaceutical development.


    • Ten years previous experience in global regulatory affairs and regulatory submissions for drugs, preferably experience in oncology.
    • Five to seven years previous experience developing and implementing global regulatory strategies for early and late stage clinical development projects with strong emphasis on approval through launch leading to post approval commercial support.
    • Previous experience managing regulatory affairs functional areas and external CROs and consultants desirable.
    • Substantial knowledge of and experience interacting and negotiating with regulatory agencies, particularly the FDA.

    Other Skills and Abilities:


    • Strong working knowledge of global regulatory requirements and submission processes.
    • Good interpersonal skills that involve working well in a team environment and the ability to lead and influence others.
    • Collaborative skills.
    • Good organizational and planning skills; results driven.
    • Excellence in written and oral communication.
    • Ability to reason, persuade and negotiate with regulatory authorities.
    • Ability to read, analyze and interpret scientific and technical information.
    • Effective analytical/problem solving skills.
    • Working knowledge of project management.

    Technical Skills:


    • Ability to read, analyze, and interpret scientific and technical journals and legal documents.
    • Ability to respond to inquiries or complaints from regulatory agencies.
    • Ability to write procedures. Ability to effectively present information to internal and external clients.


    Mathematical Skills:

    • Ability to apply mathematical concepts to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

    Reasoning Ability:

    • Ability to define problems, collect data, establish facts, and draw valid conclusions.
    • Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.

    Computer Skills:

    • Knowledge of PC software, including Microsoft Office products.


    Physical Demands: 

    • While performing the duties of this job, the employee is frequently required to sit, talk and hear.
    • The employee is occasionally required to walk.

    Work Environment: 

    • The noise level in the work environment is usually quiet.


    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.


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