Regulatory Affairs Manager

Job Summary

A company is looking for a Regulatory Affairs Manager.

Key Responsibilities

• Support the development of nonclinical/clinical regulatory strategies and plans
• Lead the preparation of regulatory submissions and maintain IND/CTAs throughout studies
• Coordinate interactions with Health Authorities and oversee administrative aspects of regulatory submissions

Required Qualifications

• Degree in health or life sciences; PhD preferred, Masters/Bachelors acceptable with relevant experience
• 4+ years of experience in regulatory affairs
• Experience in nonclinical/clinical regulatory affairs preferred
• Knowledge of regulations and guidelines relevant to regulatory submissions
• Experience collaborating with external partners such as CROs