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Regulatory Affairs Coordinator


Posted Monday, May 15, 2023

Posting ID: JP-003777622

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Edison, NJ
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This opportunity is with a LEADING global pharmaceutical company dedicated to eye health research. They are looking to add a Regulatory Specialist to their team. This company has great culture and is rapidly growing! They are looking to interview as soon as this week!


Responsible for the review and evaluation of all FDA submissions to assure accuracy and completeness of submission documents for IND/NDA/ANDA products.


  • Determines submission requirements and requests needed data, information, and documentation from pertinent departments, facilities, and affiliates, and from contractors/vendors as needed. Liaises with partner companies as appropriate.
  • Reviews and provides comment for reports and amendments to INDs/NDAs, assuring submission within specified regulatory timeframes. Reviews and provides comment for accuracy and completeness all materials to be included in submissions, including materials prepared by others and supplied to Regulatory.
  • Responsible for preparing Regulatory Module 1 documents, including labeling markups and annotations for submission.
  • Interacts with all department, facilities, and affiliates with regard to investigational and marketed products for required information and documentation.
  • Contributor for regulatory guidance regarding investigational and marketed products (U.S. and Canada).
  • Advises Regulatory Management of any delays in submissions or potential regulatory problems for investigational and marketed products (U.S. and Canada).
  • Performs other projects, project-based tasks and/or special projects as assigned by Regulatory Management.

Additional Skills & Qualifications:

  • 2-4 years of prior regulatory affairs experience
  • Basic module 1 authoring experience
  • MS office proficiency
    • You will need experience with word for forms/cover letters
    • Use excel for project tracking
    • Use Teams for project management
  • Project tracking and data entry
    • Project management system they use is Smartsheets
      • Insert data for submissions, view the dashboard to search countries and products, change dates and countries, assigning task, gathering information for projects. 
  • Excellent communication and verbal skills
  • Authoring experience for letters and forms
    • 1572 forms, 356H forms, cover letters

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