California Regulatory Affairs Manager

A company is looking for a Manager of Regulatory Affairs.

Key Responsibilities

Provide regulatory advice and manage various Regulatory Affairs activities

Plan, prepare, coordinate, and submit regulatory documents to global National Health Authorities

Conduct regulatory research to inform business strategy and assess risks

Required Qualifications, Training, and Education

Bachelor's Degree in a relevant field

At least 3 years of direct Regulatory experience

Strong working knowledge of US FDA Pharmaceutical regulations and guidance

Proven track record of successful submissions within a regulatory environment

Knowledge of EU EMA Pharmaceutical regulations is preferred