Posted to MedZilla on 1/14/2018


US-NJ, CONTRACTOR - ENTRY LEVEL WILL TRAIN - Reg. Affairs Submissions Specialist 17_0068-MZ


Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company with state of the art research capabilities that has provided innovative medicines essential to people's health for over 135 years.

In the US, Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain and anti-infectives.

The Regulatory Affairs Submissions Documentation Specialist will learn to support the Regulatory Affairs Submission Team with the preparation of regulatory documents for both eCTD as well as traditional paper submissions. The scope of this role includes assisting in the document remediation and formatting of documentation for submissions to Health Authorities.


  • Confirm proper formatting and linking of eCTD documents.
  • Provide support to the Regulatory Submissions Team.
  • Provide general assistance to the Regulatory Affairs department as needed.
  • Assist in the bookmarking, hyperlinking and QCing of electronic files for eCTD submissions.
  • Perform document formatting for both paper and eCTD submissions.


  • Bachelor s degree.
  • Familiarity with computer systems, Adobe Acrobat Standard and Microsoft Office.
  • Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.

To be considered for this position, you must apply online at: -- and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.

  • We are an Equal Opportunity Employer.
  • Please view Equal Employment Opportunity Posters provided by OFCCP here.

Please visit our website at


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.