Director, CMC Regulatory Strategy - Cell Therapy (Remote)

BioSpace; San Diego (CA); Hybrid; USD 207,000 - 253,000; Full time

Benefits offered by this job

Competitive compensation

Medical/Dental insurance benefits

Onsite gym

Wellness perks

Job summary

Aspen Neuroscience, Inc., based in San Diego, California, seeks a Director of Regulatory Affairs, CMC to lead global regulatory strategy for cell therapy programs and devices from clinical development through lifecycle management. The role blends strategic oversight with hands-on leadership in interactions with FDA and other health authorities.

This is a hybrid/remote position with some on-site collaboration.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field.
• Minimum 10 years regulatory affairs experience with CMC in biotech/med device.
• Experience leading global CMC strategy for INDs/CTAs and health authority interactions.
• Biologics/cell therapy experience required; device experience preferred.

Responsibilities

• Own and direct CMC regulatory strategy for cell therapy products and devices across development and lifecycle.
• Translate objectives into integrated CMC regulatory plans with measurable deliverables.
• Lead planning, preparation, and submission of CMC content (IND Module 3, IMPD, etc.).
• Establish CMC positions by interpreting global requirements and agency expectations.
• Direct risk assessment and mitigation for regulatory uncertainties and interdependencies.
• Provide senior regulatory direction for change controls, deviations, and GMP investigations.
• Lead CMC interactions and negotiations with FDA and other authorities.
• Serve as senior advisor to cross-functional partners to align on program objectives.
• Represent Regulatory Affairs in governance forums to enable timely decisions.
• Oversee submission readiness, budgets, and resource models.

Skills

CMC Regulatory Expertise

Strategic Leadership

Executive Communication

Cross-Functional Leadership

Regulatory Submissions

Global Health Authorities

Regulatory Risk Management

Project Management

Biologics / Cell Therapy

Device Experience

Education

Bachelor's degree in Life Sciences/Pharmacy/Engineering

10+ years regulatory affairs experience

Advanced degree preferred

Job description

Aspen Neuroscience, Inc., based in San Diego, California, seeks a Director of Regulatory Affairs, CMC to lead global regulatory strategy for cell therapy programs and devices from clinical development through lifecycle management. The role blends strategic oversight with hands-on leadership in interactions with FDA and other health authorities.

This is a hybrid/remote position with some on-site collaboration.