Director of Regulatory Affairs

Job Summary

A company is looking for a Director of Regulatory Affairs.

Key Responsibilities

• Support regulatory strategies and manage preparation of US regulatory submissions
• Ensure regulatory timelines are executed and communicate risks to senior management
• Provide regulatory review of promotional materials and lead the development of product labeling

Required Qualifications

• Bachelor's degree required; advanced degree preferred in a scientific discipline
• At least 10 years of experience in regulatory affairs within the pharmaceutical industry
• Thorough knowledge of US FDA regulations regarding product development and submissions
• Ability to develop positive relationships with regulatory authorities
• Computer literate in MS Word, MS PowerPoint, and MS Excel