Covance

  • Senior Associate Regulatory Submission

    Job Location(s) JP-Tokyo
    Job Number
    2018-17810
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    Looking to start your career? Want to be part of a global leader in Clinical Services? Come join our Clinical Development Services operations. This is a senior associate level role for Regulatory Submission role in Japan. Come Join in Covance and create a great career!

     

     

    [Responsibilities]

     

    • Prepare routine CTN and regulatory submissions packages to regulatory authorities in Japan. Will take ownership for specific pieces of work and may be the Regulatory Affairs lead for projects.
    • Assist in the coordination, collection and organization of data and information required by Regulatory Authorities
    • Assist and support Regulatory strategist in preparation PMDA meeting packages and coordination and arrangment of PMDA consultation meetings 
    • Assist and provide regulaory support to ICCC services in Japan
    • Responsible for maintaining awareness of regulatory legislation, guidance and practice pertaining to assigned product/project areas.
    • Assure compliance with regulatory requirements in relation to assigned projects.
    • Participate in project development and regulatory strategy planning sessions. Will participate independently in client meetings and will proactively liaise with clients on regulatory submission issues
    • Work on special regulatory projects as assigned.

     

    Education/Qualifications

    • Bachelor’s Degree in Life Sciences or equivalent.

    Experience

    • Excellent communication skills, organization and planning skills and attention to detail.
    • Minimum of 3 years experience in the pharmaceutical industry preferably in regulatory affairs or drug development in Japan

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