Regulatory Affairs CMC Senior Director

Job Summary

A company is looking for a Senior Director of CMC-Regulatory Affairs for their gene therapy development programs.

Key Responsibilities:

• Develop and implement regulatory CMC strategies for gene therapy programs
• Lead discussions with regulatory agencies and prepare high-quality regulatory CMC dossiers
• Build and manage a high-performing regulatory CMC team

Required Qualifications:

• Bachelor's degree in life sciences or related field
• Minimum of 10 years of experience in regulatory affairs or related functions in biotechnology or pharmaceutical industries
• Experience in gene therapy CMC
• Demonstrated experience leading eCTD formatted submissions
• Knowledge of global regulatory guidelines and regulations