Description

You will lead global CMC regulatory strategy and execution for oncology therapies, driving submissions and health authority interactions from early development through post-approval. You'll oversee a high-performing team and collaborate cross-functionally to align regulatory and technical plans.

Requirements

• Advanced degree (PhD, PharmD, or MS) in Chemistry, Pharmaceutical Sciences or related field
• Minimum 18 years biotech/pharma experience, with at least 10 in CMC regulatory affairs and global submissions
• Demonstrated success leading global CMC regulatory strategies for small-molecule products
• Proven experience scaling CMC regulatory function in a public late-stage biotech/pharma company
• Deep understanding of global regulatory frameworks (FDA, ICH, EMA, PMDA, NMPA, etc.)

Responsibilities

• Develop and execute global CMC regulatory strategies for clinical and commercial programs
• Serve as primary CMC regulatory interface with health authorities (FDA, EMA, PMDA, etc.)
• Oversee preparation and submission of CMC sections for NDAs, MAAs, and post-approval variations
• Provide strategic oversight for post-approval changes and supply chain optimization
• Build, mentor, and lead a high-performing global CMC regulatory team