Director, Regulatory Affairs Strategy

Job Summary

A company is looking for an Associate Director/Director, Regulatory Affairs (Strategy).

Key Responsibilities

• Support the development and implementation of regulatory strategies for drug, biologic, and gene therapy product advancement
• Represent Regulatory Affairs on cross-functional project teams to resolve complex project issues
• Manage and prepare regulatory submission documents, ensuring timely delivery to regulatory agencies

Required Qualifications

• Bachelor's degree in life sciences or related scientific discipline; advanced degree preferred
• Minimum of 6 years of experience in Regulatory Affairs strategy
• Demonstrated leadership ability with strong critical thinking and analytical skills
• Strategic and operational experience in managing regulatory submissions
• Ability to maintain knowledge of the shifting regulatory landscape