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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