Director, CMC Regulatory Strategy – Cell Therapy

Aspen Neuroscience, Inc.; San Diego (CA); Hybrid; USD 207,000 - 253,000; Full time

Benefits offered by this job

Competitive compensation

Medical/Dental insurance

Onsite gym

Wellness perks

Job summary

Aspen Neuroscience, Inc. in San Diego area seeks a Director of Regulatory Affairs, CMC, to provide strategic leadership and ownership of global CMC regulatory activities for cell therapy products and related delivery devices from clinical development through marketing applications and lifecycle management.

Hybrid or remote work options are available. The role requires at least 10 years of regulatory affairs experience with significant CMC expertise, proven record of global regulatory

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field.
• 10+ years of regulatory affairs experience with significant CMC exposure.
• Experience leading global CMC strategy for INDs/NTAs and health authority interactions.
• Biologics/cell therapy/medical devices experience preferred.

Responsibilities

• Own and direct CMC regulatory strategy for cell therapy products and devices.
• Lead planning, preparation, and submission of CMC content like IND Module 3 and IMPD.
• Engage with FDA and global health authorities; manage risk and inspection readiness.
• Provide senior regulatory direction across manufacturing, analytical, and quality teams.
• Build regulatory capability and lead cross-functional governance.

Skills

Regulatory strategy

CMC leadership

Executive communication

Cross-functional leadership

Risk management

Education

Bachelor’s degree in Life Sciences/Engineering

Advanced degree preferred

Tools

Microsoft Office

Adobe Acrobat

Job description

Aspen Neuroscience, Inc. in San Diego area seeks a Director of Regulatory Affairs, CMC, to provide strategic leadership and ownership of global CMC regulatory activities for cell therapy products and related delivery devices from clinical development through marketing applications and lifecycle management.

Hybrid or remote work options are available. The role requires at least 10 years of regulatory affairs experience with significant CMC expertise, proven record of global regulatory