Global CMC Regulatory Director – Cell Therapy

Position Overview

A biopharmaceutical company in Location: Louisville, KY seeks a Director of Global Regulatory Affairs CMC to lead the development and execution of regulatory strategies for products during their lifecycle. The ideal candidate will have Experience Required: over 10 years in pharmaceutical/biotech with a focus on CMC regulations, a proven track record in regulatory advice, and the ability to manage submissions to regulatory agencies. This role requires effective collaboration with cross-functional teams and offers a dynamic work environment.

Key Responsibilities

• Lead the development and execution of global regulatory CMC strategies.
• Manage submissions to regulatory agencies.
• Collaborate effectively with cross-functional teams.

Required Qualifications

• Over 10 years of experience in the pharmaceutical/biotech industry with a focus on CMC regulations.
• Proven track record in providing regulatory advice.
• Experience in managing submissions to regulatory agencies.