Director of CMC Regulatory

Job Summary

A company is looking for a Director, CMC Regulatory.

Key Responsibilities:

• Develop CMC regulatory strategies for U.S. and international markets in collaboration with cross-functional teams
• Plan, prepare, author, and review CMC-related submissions for various regulatory applications
• Monitor global regulatory requirements and trends, ensuring compliance and communicating impacts to stakeholders

Required Qualifications:

• Minimum bachelor's degree in biochemistry, chemistry, biology, chemical engineering, or related pharmaceutical science; advanced degree preferred
• 12+ years of experience in Regulatory Affairs or related role, preferably in biologics development
• Proven experience leading Regulatory CMC activities for regulatory filings in pre- and post-approval settings
• Thorough knowledge of biologics development, cGMPs, and regulatory submissions
• Experience with Emergency Use Authorizations (EUAs) and/or BLAs is a plus