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Job

Regulatory Operations Manager

  • Location

    New Jersey, USA

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Olivia Gonzalez

  • Contact email:

    o.gonzalez@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    4 days ago

  • Expiry date:

    2019-01-06

  • Startdate:

    ASAP

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!

Responsibilities:

  • 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

Experience:

  • 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 o.gonzalez@hamlynwilliams.com or 347-493-0273.