1h ago

Associate Director, Regulatory Operations and Intelligence

New York, New York

$176,400-$240,800 / year

full-timelead Remotebiotechnology

Tech Stack

Description

You'll lead global regulatory submissions and intelligence functions, managing systems and processes to support clinical programs. You'll make **strategic decisions** based on **regulatory developments** across regions. This fully remote role offers **competitive compensation** and equity.

Requirements

  • **7+** years industry experience in regulatory publishing
  • **5+** years with specialized submission systems (e.g., Lorenzo)
  • Experience with **FDA** electronic submission gateway
  • Knowledge of **CTD/eCTD** format and submissions

Responsibilities

  • Lead global regulatory submissions and intelligence gathering
  • Manage regulatory submission and publishing systems
  • Develop and enhance tools for regulatory intelligence
  • Provide training on submission processes and tools
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