Regulatory Affairs Professional

Overview

As a key member of our team, you will have the opportunity to contribute to high-quality FDA submissions and help bring innovative therapies to market. This role is ideal for detail-oriented and driven professionals who thrive in a fast-paced environment.

In this role, you will have the opportunity to work closely with a talented team of professionals who are passionate about bringing new treatments to patients. You will be responsible for preparing and submitting regulatory documents, reviewing technical documents, and providing administrative support to ensure compliance with FDA regulations.

Responsibilities

• Prepare and submit regulatory documents, including NDAs, amendments, supplements, and annual reports.
• Collaborate with the team to gather and verify documentation for timely submissions.
• Review technical documents for accuracy and regulatory compliance.
• Draft responses to FDA inquiries under supervision.
• Provide administrative support as needed.

Requirements

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