Assistant Director of Regulatory Affairs

Job Summary

A company is looking for an Assistant Director of Regulatory Affairs to join a biotechnology firm focused on life-threatening conditions.

Key Responsibilities

• Main point person responsible for writing INDs
• Spend 50-60% of time writing sections of IND with support from cross-functional teams
• Opportunity to manage a team member and gain people management experience

Required Qualifications

• Bachelor's Degree with 12 years, Master's Degree with 10 years, or PhD with 5 years of experience in biologic or pharmaceutical industries
• Must have IND experience as the point person, submitting in ECTD format through the ESG portal
• Experience in Regulatory Affairs within a pharmaceutical or biotech company