Taiho Oncology

  • Associate Director, Regulatory Affairs Advertising and Promotion

    Job Locations US-NJ-Princeton
    Category
    Regulatory
    Type
    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 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.

    Responsibilities

    • Provide regulatory support and supplement leadership and guidance to the marketing team during the development, review and approval of product labeling and advertising materials on the promotional review committee (PRC).
    • Determine and provide strategic regulatory advice on advertising and promotion materials and activities, including the development of launch materials/new claims, in accordance with business goals and objectives. 
    • Work directly with the marketing team from concept through review and approval, up to and including OPDP submissions.
    • Provide assessment of risk for marketing and medical campaigns. 
    • Work collaboratively with Compliance to ensure that materials approved by PRC are used within the intended guidelines.
    • Work with the PRC to review and approve non-promotional items such internal training documents and internal communications.
    • Represent the department to key stakeholders and agencies and make presentations as needed on current regulatory issues pertaining to Advertising and Promotional activities.
    • Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.
    • Interact effectively with functional business units in order to coordinate and facilitate documentation required for submissions, ensuring that timelines are met.
    • Provide oversight of regulatory document control activities.
    • Work collaboratively with medical and scientific personnel on development and review of materials related to advertising and promotion.
    • Participate as needed in training of sales and marketing personnel on promotional, marketing, labeling and advertising regulations.
    • Work with other regulatory team members to provide input into improvement of systems and/or processes.
    • Provide regulatory-based recommendations on marketing project initiatives and make recommendations for improvements for existing projects.
    • 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 project teams on requirements to maintain compliance with regulatory activities with emphasis on advertising and promotion compliance.
    • Contributes to the development and implementation of Corporate and Department procedures.
    • Prepare project and/or status reports as required.
    • This position requires travel.

    Qualifications

    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.

    Experience: 

    • At least 2-4 years experience for the Sr. Manager level, or 5-7 years for the Associate Director level, involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee.
    • Previous experience in global regulatory affairs and regulatory submissions for drugs, preferably experience in oncology.
    • Substantial knowledge of and experience interacting and negotiating with regulatory agencies, particularly the FDA.

    Other Skills and Abilities:

    • Current knowledge of FDA guidelines and regulations with an emphasis on product promotional activities.
    • Proven ability to prioritize and meet project deadlines.
    • Ability to determine essential components of requirements in order to include them in applicable policies and procedures.
    • 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.

    Technical Skills:

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

    Mathematical Skills:

    • Ability to apply and interpret statistical concepts in review of promotion and advertising initiatives.

    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 this position may be required to perform other duties, as assigned.

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