Senior Director, Regulatory CMC

Ladders; United States; À distance; USD 220 000 - 275 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory Leadership

CMC Regulatory

Cross-functional Collaboration

Global Submissions

Formation

Bachelor's degree in Science

Advanced degree preferred

Description du poste

For our client, we are seeking a Senior Director, Regulatory CMC to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will provide strategic leadership for global CMC regulatory activities for biologic products throughout clinical development and commercialization. The ideal candidate will guide cross-functional teams in shaping regulatory strategy, supporting high-quality submissions, and navigating Health Authority interactions across global markets. This is a highly visible opportunity to influence development decisions, manage regulatory risk, and help ensure alignment between timelines, resources, and compliance objectives.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $220,000 – $275,000 annually

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.

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.

Benefits

• Comprehensive health benefits package.
• Retirement savings plan with employer contribution.
• Paid time off and holiday observances.
• Professional development opportunities.
• Flexible work arrangements, depending on business needs.

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.