Regulatory Affairs Strategy Director

Job Summary

A company is looking for a Director of RA Strategy in the Life Sciences & Technology.

Key Responsibilities:

• Define and implement regulatory strategy for development programs
• Prepare submissions and establish regulatory processes
• Develop and manage relationships with external vendors

Required Qualifications:

• 12+ years of experience at the Director/Associate Director level in regulatory affairs
• Strong regulatory strategy development skills for nonclinical and clinical activities
• Experience with filing regulatory dossiers including INDs, CTAs, IMPDs, NDAs, MAAs, and DMFs
• Significant health authority interactions in the US and EU
• Experience in a RA strategy role at a small company preferred