Manager, Regulatory CMC (Contract)

Overview

Role responsible for supporting CMC regulatory activities in biotechnology.

Ideal candidate should have 3+ years of experience in Regulatory Affairs or related fields.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship

Locations

• United States

Requirements

• Bachelor's or master's degree in a scientific or engineering discipline
• 3+ years of experience in Regulatory Affairs or related fields
• Familiarity with ICH guidelines and US/global regulatory requirements

Responsibilities

• Contribute to CMC sections for global regulatory submissions
• Assist with compiling technical data for submissions
• Review change controls for regulatory impact