Remote Senior Director, Global CMC Regulatory Strategy

Ladders; United States; Remote; USD 220,000 - 275,000; Full time

Job summary

Ladders is seeking a Senior Director, Regulatory CMC to lead global CMC regulatory activities for biologics from clinical development through commercialization. This remote-US based role offers broad visibility to shape regulatory strategy, manage risk, and align timelines with cross-functional teams across global markets.

You will guide submissions, prepare high-quality regulatory documents, and oversee Health Authority interactions, IND/BLA/MAA planning, and regulatory pathways.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• 10+ years of Regulatory CMC experience in pharmaceuticals or biotechnology.
• Significant experience with biologic products in clinical development and commercialization.
• Comprehensive knowledge of FDA, EU, and global CMC regulations.
• Extensive preparation experience for global regulatory submissions, including IND, BLA, and MAA.
• Strong understanding of regulatory pathways for drug development.
• Prior regulatory lead experience in Health Authority interactions.
• Proficiency in Mandarin Chinese is a plus.

Responsibilities

• Provide strategic leadership for global CMC regulatory activities.
• Define and execute CMC regulatory strategies for biologics.
• Represent Regulatory CMC on senior project teams and guide development efforts.
• Lead collaboration across functions to align regulatory strategies and submissions.
• Oversee planning and creation of high-quality regulatory documents.
• Manage internal submission review processes for compliance and strategy alignment.
• Direct CMC activities related to Health Authority interactions.
• Evaluate regulatory impacts of CMC changes and direct submissions.
• Ensure alignment of timelines, resources, and objectives.
• Serve as a subject matter expert on global CMC regulations.
• Lead continuous improvement initiatives in Regulatory CMC processes.
• Escalate regulatory risks and compliance issues with recommendations.
• Maintain knowledge of global regulatory trends and translate insights.

Skills

Regulatory Leadership

CMC Regulatory

Cross-functional Collaboration

Global Submissions

Education

Bachelor's degree in Science

Advanced degree preferred

Job description

Ladders is seeking a Senior Director, Regulatory CMC to lead global CMC regulatory activities for biologics from clinical development through commercialization. This remote-US based role offers broad visibility to shape regulatory strategy, manage risk, and align timelines with cross-functional teams across global markets.

You will guide submissions, prepare high-quality regulatory documents, and oversee Health Authority interactions, IND/BLA/MAA planning, and regulatory pathways.