US Regulatory Affairs Manager

A company is looking for a US Regulatory Lead.

Key Responsibilities

Support the Global Regulatory Team in US Regulatory Activities, including IND development and submission

Act as the primary point of contact with regulatory agencies and manage local regulatory submissions

Provide guidance on local mechanisms to optimize product development and ensure compliance with regulations

Required Qualifications

Doctorate degree OR

Master's degree and 3 years of regulatory or drug development experience OR

Bachelor's degree and 8 years of industry experience OR

Associates degree and 10 years of Regulatory Affairs experience OR

High school diploma / GED and 12 years of relevant experience