California Licensed Regulatory Director

A company is looking for a Senior Director of Regulatory Affairs.

Key Responsibilities

Provides regulatory and scientific leadership to development teams for optimal success

Plans, prepares, and reviews submissions to regulatory authorities for clinical trials and marketing applications

Serves as the primary contact with regulatory agencies and manages regulatory staff development

Required Qualifications

Bachelor's degree in a life science is required; PhD, PharmD, or Master's degree preferred

Minimum of 8+ years in regulatory affairs and 12+ years in the biotech / pharma industry

Experience in oncology drug development is essential

Thorough knowledge of US and international regulations related to drug development

Experience leading regulatory agency interactions and managing INDs and clinical trial applications