Overview

We are currently seeking an Associate Director, Regulatory Operations for immediate hire in our Durham, NC office.  The selected individual will be responsible for planning, reviewing, and managing the delivery of routine submissions to meet filing deadlines globally.

 

Responsibilities include:

  • Plans, review, manages and tracks the delivery of routine regulatory submission components to meet regulatory filing deadlines in the US, Canada and Europe (e.g., INDSRs, DSURs, Information Amendments, Clinical Investigator submissions) archiving after submission.
  • Provide Regulatory support  for clinical study start up and oversight (e.g., reviewing informed consent forms, clinical trial material regulatory packets, expedited safety reporting, etc)
  • Drafts cover letters and forms as part of the submission packet.
  • Liaises with internal scientific and QA staff on regulatory submission needs
    • Manages vendors and associated contracts and budgets.
    • Prepares regular progress reports and visual presentations to facilitate information sharing
    • Assist Operations with the electronic submission process (e.g., formatting, publishing, QC of published submission)

Qualifications

  • Bachelor’s degree in scientific discipline required; advanced degree in scientific discipline a plus.
  • 5+ years of Regulatory Affairs experience in a pharma/biotech setting
  • Track record of recent, successful CTA and/or MAA submissions in Europe and IND submissions in the US
  • Excellent written and verbal communication skills
  • Ability to work independently, self-starter, problem solver, detail oriented

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