• Manager, Regulatory Affairs

    Job Locations US-NJ-Princeton
    Requisition ID
    2019-10864
  • Responsibilities

    Position Summary

    The Manager, Regulatory Affairs serves as regulatory representative to Project Teams for assigned projects or products and provides regulatory tactical support and strategy. Liaises with regulatory agencies in order to expedite approval of pending registration and answer questions. Ensures that clinical trials meet regulatory requirements as designed. Prepares and ensures rapid and timely submission of new drugs and maintain applications to sustain approved status of marketed drug.

     

    Recommends guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines.

    • Recommends regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational and marketed products.
    • Conducts regulatory research and intelligence to appropriately guide Project Teams.

    Responsible for the overall quality of regulatory submissions. Manages, Reviews and organizes documents intended for submission to FDA to assure compliance with regulatory standards. Provides appropriate regulatory guidance to Project Teams for the development of the above regulatory submissions.


    Interacts with Project Managers at FDA (pre and post submission).

     

    For assigned projects, provides effective oversight for regulatory submissions that are outsourced.

    Qualifications

    Knowledge

    • Extensive knowledge of drug development process.
    • Solid understanding of medical and clinical practices
    • Strong understanding of medical concepts and terminology, including strong knowledge of FDA Part 11 and global regulations
    • Knowledge of CFRs, ICH and FDA regulations
    • Strong knowledge of submission preparation and management

    Skills

    • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook) and Adobe Acrobat
    • Strong communication skills
    • Knows how/when to apply organizational policy or procedures to a variety of situations
      Travel 10-20%


    Education and Related Experience

    • PharmD, PhD plus minimum 2 years of pharmaceutical industry experience in regulatory affairs.
      OR
    • BS degree with minimum 5 to 7 years of pharmaceutical industry in regulatory affairs

    Overview

    Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
    In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying creativity in everything it does.
    Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 50,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016. 
     
    All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
     
     
    Disclaimer: 
     
    This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
     
    Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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