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Specialist- Regulatory eCTD Submission

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Specialist- Regulatory eCTD Submission

  • Location:

    Parsippany, New Jersey

  • Sector:


  • Job type:

    Direct Hire

  • Contact email:

    Harshita Berry

  • Job ref:


  • Published:

    15 days ago

  • Expiry date:


Specialist- Regulatory eCTD Submission

Parsippany, NJ

Job Id: 9838


Are you looking to make a career change to a stable and growing company? This exciting opportunity offers a competitive salary plus an excellent benefits package including Medical, Dental and Vision. Does this position match your future career goals? Then this opportunity could be the right fit for you.



  • Must study FDA and ICH guidance on Common Technical Document (CTD) / eCTD.
  • Responsible for communicating with FDA eSub group.
  • Must prepare and review documents for FDA submission.
  • Must prepare Investigational New Drug Applications (INDs) / New Drug Applications (NDAs) /Amendments in eCTD and submit through FDA electronic submission gateway.
  • Promotes department and company goodwill through pro-active employee communication and employee involvement.
  • Perform other tasks as assigned



  • Advance Degree in pharmaceutical/biological/computer/information system fields
  • 2+ years of experience in related field.



  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Direct Hire
  • 401K
  • Company paid Holidays


Ask for: Harshita Berry

Ajulia Executive Search is a New Jersey based Executive Search Firm specializing in retained searches in multiple sectors, including Manufacturing, Finance, IT, Legal, and Pharmaceutical. We have a nationwide client base and offer services in temporary and direct hire placements.