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Regulatory Operations Manager

  • Location

    New Jersey, USA

  • Sector:

    Life Sciences

  • Job type:


  • Salary:


  • Contact:

    Olivia Gonzalez

  • Contact email:

  • Salary high:


  • Salary low:


  • Published:

    4 days ago

  • Expiry date:


  • Startdate:


Looking for a new position with an innovative biotech in New Jersey? This trailblazing company is working on research and development of products across multiple therapeutic areas with a focus in new drug delivery technologies. Working with this collaborative team will add significant regulatory experiences to your already impressive background!


  • Ability to publish submissions electronically using eCTD software application to industry and company standards
  • Offer IND and NDA submission lifecycle maintenance support
  • Can independently format submission source documents with use of company approved templates and send for review in EDMS
  • Maintain and support regulatory systems as required
  • Produce regulatory publishing and submission processes and SOPs as needed
  • Work cross-functionally in reviewing docs from publishing standpoint as well as prepare for submission readiness


  • 5+ years of pharma experience/3-5 years of regulatory operations/submissions experience
  • MS word formatting and adobe experience preferred (Toolbox knowledge a plus)
  • Quick on feet, can work collaboratively in a team environment
  • Impeccable organizational skills and comfortable with embracing change
  • Excellent communication skills and can work in a fast-paced environment

If this amazing opportunity sounds like a role for you, please contact me directly at or 347-493-0273.