Regulatory Affairs Manager

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