Director of CMC Regulatory Affairs

Job Summary

A company is looking for a Director, CMC Regulatory Affairs.

Key Responsibilities

• Lead the CMC non-antibody team for cell and gene therapy technologies and oversee global regulatory strategies
• Direct the preparation, review, and submission of regulatory documents for FDA, EMA, and other authorities
• Provide strategic input and oversight for regulatory filings and interactions with global regulatory authorities

Required Qualifications

• Bachelor's degree in a relevant technical or scientific discipline; advanced degree strongly preferred
• Minimum of 10 years of experience in the pharmaceutical/biotech industry with at least 5 years in CMC Regulatory
• Experience in cell and gene therapies is a distinct advantage
• At least 3 years of managerial experience
• Proven track record with regulatory authorities such as FDA and EMA